BOWIE-DICK TEST CARD CATALOG NUMBER 008018— 510(k) K897045

Name: FDA 510(k) clearance K897045
Creator: U.S. Food and Drug Administration
Published: 1990-02-15

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K897045 for BOWIE-DICK TEST CARD CATALOG NUMBER 008018, Substantially Equivalent on 1990-02-15. Applicant: Edward Weck, Inc.. Device class: 2.

Clearance details

Applicant: Edward Weck, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1989-12-19
Decision date: 1990-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pa, NC, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K897045

K-number listed on FDA's recall record

Z-2417-2012 — Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has two holes in it to allow air removal and steam penetration. The preassembled test is used to evaluate the effectiveness of air removal from the sterilizer chamber during prevacuum pulse steam sterilizer cycle. Following a prevacuum cycle, the chemical bars of the Bowie-Dick Test card uniformly darken indicating that residual air has been sufficiently removed to allow complete steam penetration into the test card. If air is trapped in the card during the exposure phase of the cycle, the color change of the bars will be incomplete or uneven. Thus the card can provide an immediate indication of inadequate removal of air during a cycle. The Bowie-Dick Type test is performed in an empty chamber each day the sterilizer is to be used, usually before the first sterilization cycle.Class II·Terminated·Steris Corporation·20120703

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K897045.

Data sourced from openFDA. This site is unofficial and independent of the FDA.