← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

DEVICE CLASS
Class II
REGULATION
21 CFR 870.2300
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
11
510(K)/PMA CLEARANCES
510k: 11
0
RECALL ENTRIES

Recent clearances

K253196Midmark Corporation · 510k2026-06-12
K253436Cosinuss GmbH · 510k2026-04-30
K250135Baxter Healthcare Corp/ Excel Medical · 510k2026-01-16
K241766Fysicon BV · 510k2025-08-27
K242737Empatica S.r.l. · 510k2025-06-06
K241958Ward 24/7 Aps · 510k2025-02-14
K243146Ihealth Labs, Inc. · 510k2025-02-03
K241411Welch Allyn, Inc. · 510k2024-12-20

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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