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3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

by 3M Healthcare

510(k) K193110

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K193110; other models may be affected

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193110 Date13 Mar 2020ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1794-2022 FDA Class III initiated 25 May 2022 on shared 510(k) K193110

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
QKM
Device Class
Class II
Regulation
21 CFR Part 880.2800
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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