FDA product code · Cardiovascular
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Product code MHX covers Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II device regulated under 21 CFR 870.1025. FDA has cleared 426 devices in this code, 13 of them in the last 12 months. Median review time across the 426 most recent decisions is 112 days. openFDA lists 282 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.1025
- Review panel
- Cardiovascular
- Clearances
- 426
What is happening in MHX right now?
MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2579-2026, Z-2242-2026, Z-2243-2026, Z-2244-2026, Z-2245-2026). 2 first-time filers in the last 12 months, GLOBAL INSTRUMENTATION CORP. and Shanghai Draeger Medical Instrument Co., Ltd (K252840, K252250). Clearances are running 75% slower — a median 196 days over the last 12 months against 112 days all-time (elapsed calendar days, not FDA review days) (MHX:review_time:12m). The code is crowded, scoring 83 of 100 — 101 companies hold a clearance here and 13 arrived in the last 12 months (MHX:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2579-2026, Z-2242-2026, Z-2243-2026, Z-2244-2026, Z-2245-2026 |
| New entrant | Worth knowing | K252840, K252250 |
| Review time | Context | MHX:review_time:12m |
| Crowding | Context | MHX:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in MHX?
FDA has cleared 426 devices under product code MHX since the 510(k) programme began in 1976, 13 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | |
| K254209 | Radius VSM and Accessories | Masimo Corporation | |
| K252840 | M12 Telemetry System | Global Instrumentation, LLC | |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | |
| K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | |
| K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) | Shanghai Draeger Medical Instrument Co., Ltd. | |
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | Philips Medizin Systeme Boeblingen GmbH | |
| K252589 | Corvair Monza | AliveCor, Inc. | |
| K250854 | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) | Shenzhen Comen Medical Instruments Co.,Ltd |
How long does FDA review take for MHX?
The median FDA review time for MHX is 112 days, measured across the 426 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in MHX?
openFDA lists 282 recall records against product code MHX. A recall record covers one firm's corrective action and may span many device lots.
Z-2579-2026Open, ClassifiedPhilips North America LLC
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
Z-2242-2026Open, ClassifiedGE Medical Systems Information Technologies, Inc.
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Z-2243-2026Open, ClassifiedGE Medical Systems Information Technologies, Inc.
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Z-2244-2026Open, ClassifiedGE Medical Systems Information Technologies, Inc.
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Z-2245-2026Open, ClassifiedGE Medical Systems Information Technologies, Inc.
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Showing the 5 most recently initiated of 282. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for MHX?
MAUDE holds 9,296 adverse-event reports naming product code MHX, 2,949 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in MHX unusual?
2 months sit above MHX's own expected range: 1 March 2025, 1 October 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 118 | Insufficient history | No expected range — too little history | |
| 122 | Insufficient history | No expected range — too little history | |
| 205 | Insufficient history | No expected range — too little history | |
| 161 | Insufficient history | No expected range — too little history | |
| 188 | Insufficient history | No expected range — too little history | |
| 172 | Insufficient history | No expected range — too little history | |
| 162 | Insufficient history | No expected range — too little history | |
| 163 | Insufficient history | No expected range — too little history | |
| 205 | Insufficient history | No expected range — too little history | |
| 211 | Insufficient history | No expected range — too little history | |
| 214 | Insufficient history | No expected range — too little history | |
| 250 | Insufficient history | No expected range — too little history | |
| 231 | Insufficient history | No expected range — too little history | |
| 248 | Insufficient history | No expected range — too little history | |
| 248 | Insufficient history | No expected range — too little history | |
| 220 | Insufficient history | No expected range — too little history | |
| 218 | Insufficient history | No expected range — too little history | |
| 192 | Insufficient history | No expected range — too little history | |
| 266 | Insufficient history | No expected range — too little history | |
| 238 | Insufficient history | No expected range — too little history | |
| 278 | Insufficient history | No expected range — too little history | |
| 194 | 172–277 | Within expected (172–277) | |
| 188 | 140–235 | Within expected (140–235) | |
| 271 | 158–263 | Above expected (158–263) | |
| 284 | 175–297 | Within expected (175–297) | |
| 252 | 169–300 | Within expected (169–300) | |
| 299 | 178–321 | Within expected (178–321) | |
| 393 | 285–542 | Within expected (285–542) | |
| 314 | 215–401 | Within expected (215–401) | |
| 332 | 232–419 | Within expected (232–419) | |
| 438 | 248–405 | Above expected (248–405) | |
| 329 | 228–420 | Within expected (228–420) | |
| 424 | 258–465 | Within expected (258–465) | |
| 339 | 305–570 | Within expected (305–570) | |
| 407 | 248–443 | Within expected (248–443) | |
| 453 | 300–501 | Within expected (300–501) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in MHX.
Who has entered MHX in the last year?
2 companies filed in MHX for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| GLOBAL INSTRUMENTATION CORP. | K252840 | |
| Shanghai Draeger Medical Instrument Co., Ltd. | K252250 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in MHX?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in MHX?
Across the 426 most recent decisions, these applicants filed most often in MHX.
| Applicant | Recent clearances |
|---|---|
| Philips Medizin Systeme Boeblingen GmbH | 25 |
| Draeger Medical Systems, Inc. | 24 |
| Ge Medical Systems Information Technologies | 24 |
| Philips Medical Systems | 24 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 22 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in MHX file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| GE Medical Systems Information Technologies, Inc. | 34 | 3 |
| Philips Medical Systems, Inc. | 32 | 2 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 23 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch MHX
Get an email the morning anything changes in MHX — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Cardiovascular
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.