← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

BTT — Humidifier, Respiratory Gas, (Direct Patient Interface)

DEVICE CLASS
Class II
REGULATION
21 CFR 868.5450
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

K254078Vapotherm, Inc. · 510k2026-04-13
K251448Flexicare Medical Limited. · 510k2026-01-16
K251419Laboratorios Biogalenic S.A. DE C.V. · 510k2026-01-14
K253479Fisher & Paykel Healthcare, Ltd. · 510k2025-12-19
K250312Medline Industries, LP · 510k2025-07-02
K251611Fisher & Paykel Healthcare, Ltd. · 510k2025-06-25
K242717Laboratorios Biogalenic S.A. DE C.V. · 510k2025-01-30
K241778Medline Industries, LP · 510k2024-12-19

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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