DEVICE CLASS
Class II
REGULATION
21 CFR 880.5725
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
11
510(K)/PMA CLEARANCES
510k: 11
0
RECALL ENTRIES
Recent clearances
K252015Koru Medical Systems, Inc. · 510k2026-01-28
K251636Baxter Healthcare Corporation · 510k2025-07-28
K251640Baxter Healthcare Corporation · 510k2025-07-28
K242752Iradimed Corporation · 510k2025-05-28
K243855Carefusion 303, Inc. · 510k2025-04-25
K242115Icu Medical, Inc. · 510k2025-04-02
K242114Icu Medical, Inc. · 510k2025-04-02
K250357Deka Research & Development Corp. · 510k2025-03-11
Related on SPEQ
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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