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Bowie-Dick Test Card Catalog Number 008018

by Edward Weck, Inc.

510(k) K897045

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 NumberK897045 Date15 Feb 1990ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2417-2012 FDA Class II initiated 3 Jul 2012 on shared 510(k) K897045

    STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications. Specifically, test cards have resulted in false fail results when sterilizer performance is within acceptable ranges.

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  • Withdrawn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

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