FDA product code · Cardiovascular · Class 2
MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MHX is FDA's product code for "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)": a Class 2 device classified under 21 CFR 870.1025, reviewed by the Cardiovascular panel.
510(k) review time for MHX
Across 83 510(k) clearances under MHX decided from 2018-01-01 to 2026-10-06, the median was 195 days from FDA receipt to decision. Half took between 150 and 266 days, and 80% were decided within 269 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 150 |
| Median | 195 |
| 75th percentile | 266 |
| 80th percentile | 269 |
| 90th percentile | 399 |
| Slowest | 582 |
| Year | Median days | n |
|---|---|---|
| 2018 | 203 | 11 |
| 2019 | 243 | 7 |
| 2020 | 196 | 11 |
| 2021 | 195 | 5 |
| 2022 | 189 | 15 |
| 2023 | 229 | 8 |
| 2024 | 181 | 5 |
| 2025 | 192 | 8 |
| 2026 (to 10-06, partial) | 202 | 13 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MHX in the public FDA record
| 510(k) clearances, all years | 430 |
|---|---|
| Device recalls | 285 |
| Establishment listings | 560 |
| GUDID device identifiers | 2,467 |
Counts of records, not of devices or events. Adverse event reports for MHX are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MHX
3 FDA recognized consensus standards cite MHX, 2 of them recognized only in part, among them ANSI AAMI EC57:2012; ANSI AAMI EC53:2013/(R)2020; IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-118 ANSI AAMI EC57:2012 — Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
- 3-129 ANSI AAMI EC53:2013/(R)2020 (partial recognition) — ECG trunk cables and patient leadwires
- 3-203 IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION (partial recognition) — Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.