← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

BZD — Ventilator, Non-Continuous (Respirator)

DEVICE CLASS
Class II
REGULATION
21 CFR 868.5905
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
19
510(K)/PMA CLEARANCES
510k: 19
0
RECALL ENTRIES

Recent clearances

K253553Resmed Corp · 510k2026-06-04
K254104Resmed Corp · 510k2026-05-27
K251920Dcstar, Inc. · 510k2026-05-21
K253166BMC Medical Co., Ltd. · 510k2026-04-29
K252338Somnetics International, Inc. (Dba Transcend Inc) · 510k2026-04-17
K251847Sleepnet Corporation · 510k2026-01-15
K253939RemSleep Holdings, Inc. · 510k2026-01-07
K251770Sleepres, Inc. · 510k2025-12-15

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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