Recent FDA 510(k) Clearances for Patient-Monitoring Devices: Product Codes, Predicates, and Intended Uses
Patient monitoring is one of the highest-volume areas of the 510(k) program, and the clearance record is the practical reference point for anyone planning a submission in the space. Which product code a device falls under determines the review pathway, the applicable special controls, and the pool of devices available as predicates. Reading the recent decisions tells a regulatory team what FDA has accepted as substantially equivalent, how intended-use language is being framed, and where a new indication is likely to push a device outside its predicate's boundaries.
The analysis below reviews recent 510(k) clearances for patient-monitoring devices, organized by product code. For each category it identifies representative cleared devices, the predicates cited in support of substantial equivalence, and the intended-use statements as they appear in the decision record, with links back to the underlying FDA documents.
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Recent FDA 510(k) clearances for patient-monitoring devices: product codes, predicates, and intended uses
Patient monitoring remains one of the most active corners of the FDA 510(k) program, and the clearances issued over the past year map cleanly onto a handful of product codes. At the volume end sit non-invasive electronic blood-pressure monitors (product code DXN), which account for the single largest share of recent clearances in this space: a review of recent decisions found DXN devices such as the Shenzhen Ziqing Wrist Blood Pressure Monitor (XW-05) 65, the Tournicare ARMA Automatic Blood Pressure Monitor 102, and the Shenzhen Jamr Blood Pressure Monitor (W06LT) 27 clearing on a near-weekly cadence. Above that commodity tier, the more clinically substantive clearances fall into multi-parameter bedside monitors (MHX), spot-check vital-signs devices (MWI), camera-based contactless vital-signs software (QME), and a set of specialty monitors covering hemodynamics (DQK), neurology (OMC), neuromuscular transmission (KOI), ambulatory cardiac rhythm (MWJ), and capnography (CCK).
The pattern across these submissions is conventional: nearly every clearance rests on substantial equivalence to a single primary predicate, very often the applicant's own prior-generation device, with the intended-use statement carried forward largely unchanged. The sections below walk through representative recent clearances in each category with their product code, predicate lineage, and intended use.
Summary of representative clearances
| Device (K-number) | Company | Product code | Decision date | Primary predicate |
|---|---|---|---|---|
| ePM Series Patient Monitor (K260098) 146 | Shenzhen Mindray | MHX | 2026-05-20 | K200015 (own ePM Series) 188 |
| uMEC 60–150 Patient Monitors (K253170) 124 | Shenzhen Mindray | MHX | 2026-04-16 | K200015 (Mindray ePM Series) 124188 |
| IntelliVue MMM X3 / MX100 / MMX (K252726) 126 | Philips | MHX | 2026-02-06 | K230604 (own IntelliVue) 178 |
| Midmark 800 Digital Vital Signs Device (K253196) 8 | Midmark | MWI | 2026-06-12 | K161909 (IQvitals Zone) 181 |
| SmartSpectra Vital Signs Monitor 1.0 (K254169) 1 | Presage Security | QME | 2026-06-18 | K211906 (Oxehealth Vital Signs) 185 |
| PanopticAI Vital Signs (K260066) 5 | PanopticAI | QME | 2026-05-21 | K240890 / K211906 4185 |
| Vital Signs (K251200) 2 | Oxehealth | QME | 2026-02-02 | K211906 (own Vital Signs) 185 |
| HemoSphere Nano Monitor (K253186) 28 | Edwards Lifesciences | DQK | 2026-02-24 | K243781 (HemoSphere Advanced) 135 |
| Ceribell Monitor (K261101) 14 | Ceribell | OMC | 2026-06-30 | K170363 / K231366 186177 |
| TetraGraph NMT Monitor (K261098) 133 | Senzime | KOI | 2026-05-22 | K220530 (own TetraGraph) 187 |
| mobiCARE Cardiac Monitoring System (K253384) 120 | Seers Technology | MWJ | 2026-06-25 | K231289 (S-Patch Ex ECG Patch) 184 |
| Capnostream35 Portable Respiratory Monitor (K253030) 66 | Covidien | CCK | 2026-05-01 | K200594 (Capnostream 35) 179 |
Multi-parameter bedside monitors (product code MHX)
These are the classic acute-care patient monitors: multi-parameter systems that display, alarm on, and store several physiological signals at once. Mindray's ePM Series (K260098) is described as intended for monitoring, displaying, reviewing, storing, alarming, and transferring multiple physiological parameters including ECG (3-, 5-, 6-, or 12-lead selectable, with arrhythmia detection, ST-segment analysis, QT analysis, and heart rate) and respiration rate, among others 146. Its predicate is Mindray's own earlier ePM Series Patient Monitors (K200015, cleared 2020-06-08) 188.
Mindray's lower-acuity uMEC 60/70/80/100/120/150 Patient Monitors (K253170) were cleared by claiming the same indications for use as the primary predicate ePM Series (K200015), the same use environment (healthcare facilities), and the same patient population of adult, pediatric, and neonatal patients 124. This is a textbook family-extension play: the applicant reuses its own cleared platform as the predicate and argues equivalence of indications rather than novelty.
Philips' IntelliVue Multi-Measurement Module X3, Patient Monitor MX100, and MMX (K252726) is intended to monitor, record, and generate alarms for multiple physiological parameters in adults, pediatrics, and neonates 126. The predicate is Philips' own prior IntelliVue MX100 / Multi-Measurement Module X3 clearance (K230604, 2023-11-22) 178. Across all three MHX clearances the predicate is the applicant's own prior-generation monitor, underscoring how mature this device class is and how narrow the incremental changes tend to be.
Spot-check vital-signs devices (product code MWI)
The Midmark 800 Digital Vital Signs Device (K253196) is intended for use by clinicians and other medically qualified personnel to measure specific physiologic parameters in adult and pediatric patients, providing non-invasive measurements such as blood pressure for patients 2 years and older 8. Its primary predicate is Midmark's own IQvitals Zone (K161909) 181, and the submission additionally references component predicates including the Masimo Rad-97 pulse CO-oximeter (K193242, MWI) 180, the Nellcor OxiMax N-600x pulse oximeter system (K123581) 189, and the Exergen TemporalScanner thermometer (K011291) 182 to cover the individual measurement modules bundled into the device. This multi-predicate structure is typical for spot-check "vitals carts" that integrate several previously cleared measurement technologies under one enclosure.
Contactless, camera-based vital-signs software (product code QME)
The most technologically distinctive recent activity is in QME, a software-driven category for non-contact spot measurement of pulse rate and respiratory rate from video. Oxehealth's Vital Signs device (K251200) is the reference point: it is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest-wall movements) when the subject is still, using software that assesses video footage from a fixed-installation camera in single-occupancy hospital rooms 2. It cites Oxehealth's own earlier Vital Signs clearance (K211906) as predicate 185.
Two newer entrants build on the same predicate. Presage Security's SmartSpectra Vital Signs Monitor 1.0 (K254169) is a non-invasive spot-check device for pulse rate and respiratory rate (via chest-wall movement) that names the Oxehealth Vital Signs device (K211906) as predicate 1185. PanopticAI's Vital Signs (K260066) is likewise intended for non-invasive spot measurement of pulse rate and breathing rate, citing PanopticAI's own prior clearance (K240890) and the Oxehealth device (K211906) 54185. The convergence on a single originating predicate (K211906) shows how one De Novo-style novel clearance can seed an entire follow-on cohort under a shared product code.
Advanced hemodynamic monitoring (product code DQK)
Edwards Lifesciences' HemoSphere Nano Monitor (K253186), when used with a compatible non-invasive finger cuff, is indicated for adult patients (18 years and older) in whom cardiac-function parameters need to be evaluated as part of a patient assessment; the monitor and cuffs non-invasively measure blood pressure and associated hemodynamic parameters 28. The predicate is Edwards' own HemoSphere Advanced Monitor platform and associated modules (K243781, cleared 2025-07-23) 135, again a same-manufacturer platform extension.
Neurological monitoring (product code OMC)
Ceribell's Monitor (K261101) is intended to acquire, transmit, display, and store electroencephalogram (EEG) and, optionally, electrocardiogram (ECG) and video, for prescription use in professional healthcare facilities; the submission states the subject device has the same intended use as its predicates 14. It relies on Ceribell's own Pocket EEG Device (K170363) 186 together with BioSerenity's Neuronaute Plus (K231366) 177 as predicates, pairing the applicant's platform predicate with a second cleared EEG system to support the technological-characteristics comparison.
Neuromuscular transmission monitoring (product code KOI)
Senzime's TetraGraph Neuromuscular Transmission Monitor (K261098), with its TetraSens and TetraHub accessories, carries an intended-use and indications-for-use statement identical to its predicate, the earlier TetraGraph (K220530) 133187. The submission documents the same anesthesiology review panel and the same classification regulation (21 CFR 868.2775) as the predicate 133, with Senzime's original TetraGraph clearance (K190795) also in the device's lineage 183.
Ambulatory cardiac rhythm monitoring (product code MWJ)
Seers Technology's mobiCARE Cardiac Monitoring System (K253384) is a wearable, ambulatory ECG recorder indicated for use on patients who may be asymptomatic or who may present transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, chest pain, and/or anxiety 120. Its predicate is the S-Patch Ex Wearable ECG Patch (K231289) from Wellysis Corp. 184, one of the few clearances in this set that leans on a third party's device rather than the applicant's own.
Capnography and respiratory monitoring (product code CCK)
Covidien's Capnostream35 Portable Respiratory Monitor (K253030) provides non-invasive monitoring of expired and inspired carbon-dioxide concentration (EtCO2), respiration rate from capnography, arterial oxygen saturation (SpO2), and pulse rate, for neonatal, pediatric, and adult patients 66. The predicate is the earlier Capnostream 35 Portable Respiratory Monitor (K200594) from Oridion Medical 179, with the intended use carried forward and the apnea-per-hour and oxygen-desaturation-index indications limited to adult patients 66.
What the pattern tells reviewers
Three observations stand out for anyone planning a submission in this space. First, product-code selection is doing a lot of work: the same "patient monitor" search term surfaces everything from a commodity DXN wrist cuff 65 to a Class II advanced hemodynamic platform (DQK) 28, so precise product-code scoping is essential before benchmarking a predicate. Second, same-manufacturer predicates dominate. Mindray, Philips, Edwards, Senzime, Oxehealth, and Covidien each cleared their newest device against their own prior generation 188178135187185179, which keeps the substantial-equivalence argument narrow and the intended-use language stable. Third, the contactless camera-based vital-signs cohort (QME) is the category to watch: multiple independent applicants are now converging on a single originating predicate (Oxehealth's K211906) 18515, a signature of an emerging device type moving from novel clearance toward a settled 510(k) pathway.
A reader who needs the full predicate tree for any one of these devices, the complete indications-for-use text, or the technological-characteristics comparison tables can ask Rhizome to pull the specific 510(k) summary and trace the predicate chain back through prior generations.