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FDA PRODUCT CODE · CLASS II

BTA — Pump, Portable, Aspiration (Manual Or Powered)

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4780
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
14
510(K)/PMA CLEARANCES
510k: 14
0
RECALL ENTRIES

Recent clearances

K253629Shenzhen Root Innovation Technology Co., Ltd. · 510k2026-05-26
K260134Shenzhen Root Innovation Technology Co., Ltd. · 510k2026-05-15
K260892Shenzhen HugeMed Medical Technical Development Co., Ltd. · 510k2026-05-14
K260473Shenzhen Kingboom Technology Co., Ltd. · 510k2026-05-12
K253107Shenzhen Dongjiang Technology Co., Ltd. · 510k2026-04-14
K260147Shenzhen Kingboom Technology Co., Ltd. · 510k2026-03-13
K251450Shenzhen Desida Technology Co., Ltd. · 510k2025-06-06
K244033Shenzhen Desida Technology Co., Ltd. · 510k2025-05-16

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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