DEVICE CLASS
Class II
REGULATION
21 CFR 870.1650
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES
Recent clearances
K252652Fortis Biosolutions Company Limited · 510k2026-05-14
K252638Acist Medical Systems, Inc. · 510k2026-05-13
K252653Acist Medical Systems, Inc. · 510k2026-05-13
K253048Shenzhen Maiwei Biotech Co., Ltd. · 510k2026-04-16
K251788Zhuhai DR Medical Instruments Co., Ltd. · 510k2026-03-05
K252891Bayer Medical Care, Inc. · 510k2026-02-13
K244038Shandong Int Medical Instruments Co., Ltd. · 510k2025-09-05
K242143Shandong Int Medical Instruments Co., Ltd. · 510k2024-12-23
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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