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Continuous Ventilator V61-1012

by Flight Medical Innovations Ltd

Continuous Ventilator V61-1012 is an anaesthesia ventilator (FDA Class II; FDA product code CBK, Ventilator, Continuous, Facility Use) made by Flight Medical Innovations Ltd, cleared under FDA 510(k) K130171 on 8 Apr 2014 and listed in FDA GUDID since 29 Sep 2017 (UDI-DI 17290013641110), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K130171

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17290013641110 UDI-DI Date29 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130171 Date8 Apr 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130171 decided 8 Apr 2014 Active
  • FDA GUDID UDI-DI 17290013641110 listed 29 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130171
  2. Listed FDA GUDID 17290013641110

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Continuous Ventilator
Generic name
Anaesthesia ventilator
Model / reference
V61-1012
Primary DI / UDI-DI
17290013641110
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
MRI safety
MR Unsafe

Related devices

Category: Transport electric ventilatorAnaesthesia ventilator

Cleared under the same submission (K130171)

and 3 more cleared under K130171

Similar devices

Other devices filed under FDA product code CBK (Ventilator, Continuous, Facility Use).

Other devices from Flight Medical Innovations Ltd

See all devices from Flight Medical Innovations Ltd →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)