Device type
Ventilator, Non-Continuous (Respirator)
Product code BZD · Class II · 21 CFR 868.5905 · Anesthesiology
Recent 510(k)s
Oct 23, 2026
K260251
BreathCare PAP III (YH-390N)
Suzhou Yuyue Medical Technology Co., Ltd.
- BZD
- Class II
Sep 25, 2026
K261262
Altis Full Face Mask
Respironics, Inc.
- BZD
- Class II
Recent recalls
Sep 30, 2026
Z-3140-2026
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709,…
CooperSurgical, Inc.
- BZD
- Class I
- Ongoing
Sep 30, 2026
Z-3139-2026
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-27…
CooperSurgical, Inc.
- BZD
- Class I
- Ongoing