FDA product code MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MHX is the FDA product code for monitor, physiological, patient(with arrhythmia detection or alarms). It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel. FDA has cleared 430 510(k) submissions under MHX, 49 in the last five years, from 115 different applicants. The average 510(k) review took 139 days (median 112); 221 days on average over the last three years. FDA has posted 286 recalls for MHX devices, 85 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Regulation | 21 CFR 870.1025 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for MHX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 14 | 140 |
| 2018 | 11 | 206 |
| 2019 | 7 | 254 |
| 2020 | 11 | 193 |
| 2021 | 5 | 251 |
| 2022 | 15 | 210 |
| 2023 | 8 | 240 |
| 2024 | 5 | 224 |
| 2025 | 8 | 202 |
| 2026 | 13 | 238 |
Compare with all 510(k) review times · Search every MHX clearance
Top MHX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Draeger Medical Systems, Inc. | 25 | 2026-08-20 |
| Philips Medizin Systeme Boeblingen GmbH | 25 | 2026-02-06 |
| Philips Medical Systems | 24 | 2019-08-06 |
| Ge Medical Systems Information Technologies | 24 | 2010-02-24 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 22 | 2026-05-20 |
110 more applicants have MHX clearances. See the full list in Caduvo.
Most recent MHX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260656 | GE Healthcare Finland Oy | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M | 2026-09-01 | 186 |
| K260343 | GE Healthcare Finland Oy | Carescape Canvas 1000; Carescape Canvas Smart Display | 2026-08-28 | 207 |
| K260579 | Draeger Medical Systems, Inc. | Infinity® Acute Care System (IACS) VG8.1 | 2026-08-20 | 181 |
| K251508 | Edan Instruments, Inc. | Telemetry Monitor (iT30, iT50) | 2026-08-06 | 447 |
| K253277 | Ge Medical Systems Information Technologies, Inc. | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | 2026-07-24 | 298 |
Recalls for MHX devices
286 product recalls in 201 recall events; 85 initiated in the last five years and 118 still open. Most recent: 2026-07-31.
| Year | Recalls |
|---|---|
| 2017 | 16 |
| 2018 | 19 |
| 2019 | 17 |
| 2020 | 8 |
| 2021 | 3 |
| 2022 | 7 |
| 2023 | 9 |
| 2024 | 19 |
| 2025 | 37 |
| 2026 | 13 |
Frequently asked questions
What is FDA product code MHX?
MHX is the FDA product code for monitor, physiological, patient(with arrhythmia detection or alarms). It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel.
What device class is MHX?
Class II, regulation 21 CFR 870.1025. Typical premarket route: 510(k).
How long does a 510(k) take for product code MHX?
Across 430 cleared submissions the average was 139 days from receipt to decision (median 112).
Which companies have the most MHX clearances?
Draeger Medical Systems, Inc. (25); Philips Medizin Systeme Boeblingen GmbH (25); Philips Medical Systems (24); Ge Medical Systems Information Technologies (24); Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (22).
Have MHX devices been recalled?
Yes: 286 product recalls across 201 recall events; the most recent began 2026-07-31.
Next steps
- Run an FDA pathway report with predicate devices for product code MHX
- Run a recall and safety report across every MHX manufacturer
- Watch product code MHX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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