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FDA PRODUCT CODE · CLASS II

CAF — Nebulizer (Direct Patient Interface)

DEVICE CLASS
Class II
REGULATION
21 CFR 868.5630
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES

Recent clearances

K260270FindAir Sp. z o.o. · 510k2026-06-02
K251572Pari Respiratory Equipment, Inc. · 510k2025-12-19
K251659Qingdao Future Medical Technology Co., Ltd. · 510k2025-11-14
K244035Shenzhen Jermei Medical Device Technology Co., Ltd. · 510k2025-09-19
K243468Joytech Healthcare Co. , Ltd. · 510k2025-07-02
K250022Voluntis · 510k2025-06-30
K250583Hcmed Innovations Co., Ltd. · 510k2025-06-20
K242354Enchant Tek Co. , Ltd. · 510k2025-04-29

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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