FDA product code · Cardiovascular

Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Name: FDA decisions, review times, recalls and adverse event reports for product code MHX
Creator: 510(k) Report

MHXClass II21 CFR 870.1025510(k) required431 decisions since 1987168 recalls

431 FDA decisions since 1987. 510(k) reviews decided 2021–2025 took a median of 192 days (half between 153 and 256). 168 recalls name this code, 0 of them Class I. The most-cited predicate is K041235, named by 32 later devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of MHX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	15	96	3	131
2008	16	58	2	232
2009	13	57	7	382
2010	20	90	13	955
2011	12	81	16	949
2012	16	88	11	676
2013	21	120	14	1,997
2014	13	248	6	1,609
2015	14	203	5	1,284
2016	13	149	7	1,105
2017	14	134	6	1,115
2018	11	203	12	2,157
2019	7	243	6	1,462
2020	11	196	0	1,714
2021	5	195	0	2,423
2022	15	189	6	1,470
2023	8	229	3	2,254
2024	5	181	3	2,814
2025	8	192	15	3,761
2026	14	205	21	—

FIG. 1 — MHX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MHX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do MHX devices cite most?

Devices in this code that later submissions most often claim equivalence to.

K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 200432cite it
K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 200531cite it
K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless…Philips Medical Systems, Inc. · 200329cite it
K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 200429cite it
K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry Monitoring System IIPhilips Medical Systems, Inc. · 200427cite it
K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH · 200625cite it

Which MHX devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX…Philips Medizin Systeme Boeblingen GmbH · 202641generations
K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH · 202541generations
K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor…Philips Medizin Systeme Böblingen GmbH · 202541generations
K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4…Philips Medizin Systeme Böblingen GmbH · 202540generations
K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH · 202340generations
K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH · 202340generations

What has FDA decided in MHX lately?

K260676Radius VSM and AccessoriesMasimo Corporation · 2026
K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026
K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc. · 2026

All 431 MHX decisions →

What has been recalled in MHX lately?

Z-0199-2027Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;Philips North America · Sep 16, 2026Class II
K102376Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number…Nihon Kohden America LLC · Sep 8, 2026Class II
K190011T1 Patient Monitor. Operator's Manual: T1 Patient MonitorMindray DS USA, Inc. · Aug 31, 2026Class III
K260098ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM…Mindray DS USA, Inc. · Aug 31, 2026Class III
K153448Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / VMindray DS USA, Inc. · Aug 31, 2026Class III
K153448cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12Mindray DS USA, Inc. · Aug 31, 2026Class III

Related product codes

Other codes under 21 CFR 870.1025.

MLD Monitor, St Segment With Alarm QYX Outpatient Cardiac Telemetry QYW Hospital Cardiac Telemetry MXD Recorder, Event, Implantable Cardiac, (With…DSI Detector And Alarm, Arrhythmia