# K897045: Bowie-Dick Test Card Catalog Number 008018

- Pathway: 510(k) (Traditional)
- Applicant: Edward Weck, Inc.
- Decided: Feb 15, 1990 after 58 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 3, 2012 · Class II · Z-2417-2012: 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 withi

Source page: https://510kreport.com/device/K897045
Methodology: https://510kreport.com/methodology