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Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus

by Smiths Medical International, Ltd.

510(k) K051322

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051322 Date5 Aug 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0991-2007 FDA Unclassified (pre-2012) initiated 16 May 2007

    Smiths Medical is conducting a recall of 93 Pneupac VR1 Emergency & Transport Ventilators following the identification of a problem which may exist with the demand valve that could cause the ventilator to stop cycling & to deliver continuous flow output to the patient.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTL
Models / Variants
FDA applicant
Smiths Medical International , Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5925
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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