Penlon AV-S Remote
by Penlon, Ltd.
Penlon AV-S Remote is a Class II device made by Penlon, Ltd., cleared under FDA 510(k) K051222 on 23 Sep 2005 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 05051977000055), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05051977000055 | Date24 Sep 2015 | StatusListed |
| United States | FDA 510(k) | NumberK051222 | Date23 Sep 2005 | StatusActive |
Official records
- AccessGUDID record 05051977000055
- FDA 510(k) database K051222
Across registries
- FDA 510(k) K051222 decided 23 Sep 2005 Active
- FDA GUDID UDI-DI 05051977000055 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K051222
- Listed FDA GUDID 05051977000055
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Penlon
- Generic name
- Anaesthesia ventilator
- Model / reference
- AV-S Remote
- Primary DI / UDI-DI
- 05051977000055
- 510(k) Number
- FDA product code
- CBK
- GMDN term
- Anaesthesia ventilator
- Device class
- Class II
- Regulation number
- 868.5895
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code CBK (Ventilator, Continuous, Facility Use).
- BIRD AVEA VENTILATOR by Bird Products Corp.
- BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM by Breathe Technologies, Inc.
- PENLON ANESTHESIA VENTILATOR SERIES 300 by Bear Medical Systems, Inc.
- TV-100 by Bio-Med Devices, Inc.
- VentStar Carina ExpV 200cm 5704962 by Drägerwerk AG & Co. KGaA
- Ventstar Oxylog 1000 180 2M86837 by Drägerwerk AG & Co. KGaA
- Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask by Sleepnet Corporation
- MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR by Eastern Anesthesia, Inc.
- Performax Mask, Single Use w/SE, Small 1061621 by Respironics Inc.
- RESPOND(R) Ventilator by CORVENT MEDICAL, INC