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Uni-Vent-731 Series Ventilators, Model 731EMV+

by Impact Instrumentation, Inc.

510(k) K091238

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 NumberK091238 Date13 Aug 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0812-2018 FDA Class II initiated 30 Jun 2017

    A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.

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  • Withdrawn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
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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