DEVICE CLASS
Class II
REGULATION
21 CFR 868.2375
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES
Recent clearances
K253274Intelligent Dots, LLC · 510k2026-06-25
K251326Edwards Lifesciences, LLC · 510k2026-06-11
K250093Linshom Medical, Inc. · 510k2025-09-26
K250934Respiree Pte, Ltd. · 510k2025-08-05
K243183Rtm Vital Signs, LLC · 510k2025-06-27
K243966Faceheart Corp. · 510k2025-04-09
K242001Philips Medical Systems Nederland B.V. · 510k2025-04-04
K233953Makani Science, Inc. · 510k2025-03-28
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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