FDA product code · Cardiovascular · Class 2
MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWI is FDA's product code for "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)": a Class 2 device classified under 21 CFR 870.2300, reviewed by the Cardiovascular panel.
510(k) review time for MWI
Across 74 510(k) clearances under MWI decided from 2018-01-01 to 2026-10-06, the median was 222 days from FDA receipt to decision. Half took between 129 and 279 days, and 80% were decided within 308 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 129 |
| Median | 222 |
| 75th percentile | 279 |
| 80th percentile | 308 |
| 90th percentile | 358 |
| Slowest | 602 |
| Year | Median days | n |
|---|---|---|
| 2018 | 217 | 11 |
| 2019 | 255 | 14 |
| 2020 | 138 | 8 |
| 2021 | 161 | 9 |
| 2022 | 231 | 5 |
| 2023 | 250 | 8 |
| 2024 | 202 | 10 |
| 2026 (to 10-06, partial) | 259 | 5 |
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.
MWI in the public FDA record
| 510(k) clearances, all years | 308 |
|---|---|
| Device recalls | 81 |
| Establishment listings | 373 |
| GUDID device identifiers | 1,983 |
Counts of records, not of devices or events. Adverse event reports for MWI 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 MWI
6 FDA recognized consensus standards cite MWI, 1 of them recognized only in part, among them IEEE Std 11073-10406-2023; IEEE Std 11073-10406-2011; ISO IEEE 11073-10102 First edition 2014-03-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 13-147 IEEE Std 11073-10406-2023 — Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
- 13-56 IEEE Std 11073-10406-2011 — Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
- 13-75 ISO IEEE 11073-10102 First edition 2014-03-01 — Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
- 13-76 ISO 11073-91064 First edition 2009-05-01 — Health informatics - Standard communication protocol - Computer-assisted electrocardiography
- 3-129 ANSI AAMI EC53:2013/(R)2020 (partial recognition) — ECG trunk cables and patient leadwires
- 3-155 IEC 60601-2-47 Edition 2.0 2012-02 — Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.