Product code MWI: 510(k) clearances and predicates
Product code MWI covers Vital Signs Monitor (CLEO2). FDA lists 308 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
308 clearances on file under product code MWI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 5 |
| 2023 | 8 |
| 2024 | 10 |
| 2025 | 4 |
| 2026 so far | 5 |
Recent clearances
Newest MWI clearances in the FDA index, with applicant and decision date:
- K260438, Vital Signs Monitor (CLEO2), applicant Infinium Medical, Inc., decided 2026-08-14. FDA record
- K253417, Masimo Root Monitoring System, applicant Masimo Corporation, decided 2026-08-12. FDA record
- K253196, Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400), applicant Midmark Corporation, decided 2026-06-12. FDA record
- K253436, c-med0 alpha, applicant Cosinuss GmbH, decided 2026-04-30. FDA record
- K250135, WAVE Clinical Platform (2.0.000), applicant Baxter Healthcare Corp/ Excel Medical, decided 2026-01-16. FDA record
- K241766, QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid), applicant Fysicon BV, decided 2025-08-27. FDA record
- K242737, Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal, applicant Empatica S.r.l., decided 2025-06-06. FDA record
- K241958, WARD-CSS (v1.2.x), applicant Ward 24/7 Aps, decided 2025-02-14. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Masimo Root Monitoring System, Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400). Watch new MWI clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code MWI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MWI clearances include Vital Signs Monitor (CLEO2).
How many 510(k) clearances use product code MWI?
308 at the time this page was generated, from openFDA records.
How do I find a predicate device under MWI?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new MWI clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.