FDA product code MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWI is the FDA product code for monitor, physiological, patient (without arrhythmia detection or alarms). It is a Class II device, regulated under 21 CFR 870.2300 and reviewed by the Cardiovascular panel. FDA has cleared 308 510(k) submissions under MWI, 32 in the last five years, from 137 different applicants. The average 510(k) review took 139 days (median 116); 246 days on average over the last three years. FDA has posted 85 recalls for MWI devices, 26 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | Class II |
| Regulation | 21 CFR 870.2300 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MWI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 13 | 199 |
| 2018 | 11 | 200 |
| 2019 | 14 | 229 |
| 2020 | 8 | 158 |
| 2021 | 9 | 192 |
| 2022 | 5 | 263 |
| 2023 | 8 | 290 |
| 2024 | 10 | 207 |
| 2025 | 4 | 263 |
| 2026 | 5 | 267 |
Compare with all 510(k) review times · Search every MWI clearance
Top MWI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Larsen & Toubro Limited | 15 | 2011-03-15 |
| Masimo Corporation | 13 | 2026-08-12 |
| Welch Allyn, Inc. | 12 | 2024-12-20 |
| Agilent Technologies, Inc. | 11 | 2001-07-20 |
| Airstrip Technologies, LP | 8 | 2014-02-14 |
132 more applicants have MWI clearances. See the full list in Caduvo.
Most recent MWI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260438 | Infinium Medical, Inc. | Vital Signs Monitor (CLEO2) | 2026-08-14 | 184 |
| K253417 | Masimo Corporation | Masimo Root Monitoring System | 2026-08-12 | 315 |
| K253196 | Midmark Corporation | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | 2026-06-12 | 259 |
| K253436 | Cosinuss GmbH | c-med0 alpha | 2026-04-30 | 211 |
| K250135 | Baxter Healthcare Corp/ Excel Medical | WAVE Clinical Platform (2.0.000) | 2026-01-16 | 364 |
Recalls for MWI devices
85 product recalls in 63 recall events; 26 initiated in the last five years and 28 still open. Most recent: 2026-08-21.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 5 |
| 2020 | 6 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 6 |
| 2025 | 7 |
| 2026 | 10 |
Frequently asked questions
What is FDA product code MWI?
MWI is the FDA product code for monitor, physiological, patient (without arrhythmia detection or alarms). It is a Class II device, regulated under 21 CFR 870.2300 and reviewed by the Cardiovascular panel.
What device class is MWI?
Class II, regulation 21 CFR 870.2300. Typical premarket route: 510(k).
How long does a 510(k) take for product code MWI?
Across 308 cleared submissions the average was 139 days from receipt to decision (median 116).
Which companies have the most MWI clearances?
Larsen & Toubro Limited (15); Masimo Corporation (13); Welch Allyn, Inc. (12); Agilent Technologies, Inc. (11); Airstrip Technologies, LP (8).
Have MWI devices been recalled?
Yes: 85 product recalls across 63 recall events; the most recent began 2026-08-21.
Next steps
- Run an FDA pathway report with predicate devices for product code MWI
- Run a recall and safety report across every MWI manufacturer
- Watch product code MWI 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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