Device type
Ventilator, Continuous, Facility Use
Product code CBK · Class II · 21 CFR 868.5895 · Anesthesiology
Recent 510(k)s
No 510(k) clearances in the archive for CBK.
Recent recalls
Oct 28, 2026
Z-0127-2027
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0132-2027
V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0131-2027
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0128-2027
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0126-2027
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0123-2027
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0125-2027
VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0130-2027
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0129-2027
V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used fo…
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0133-2027
V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0124-2027
VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0122-2027
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing