# DEN230068: 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190

- Pathway: De Novo (Direct)
- Applicant: 3M Company
- Decided: May 21, 2024 after 235 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
3M™ Attest eBowie Dick Test Card and 3M™ Attest eBowie-Dick Card Holder As a Sterilizer Monitoring Device, the 3M™ Attest™ eBowie-Dick Test Card 10135 and 3M™ Attest™ eBowie-Dick Card Holder 10135CH is used in conjunction with the 3M™ Attest™ eBowie-Dick Auto-reader 1190 to monitor the equipment performance of steam sterilizers each day, as well as after a steam sterilizer repair. The 3M™ Attest™ eBowie-Dick Test Card 10135 will detect steam penetration as a means of measuring air removal efficiency. The 3M™ Attest™ eBowie-Dick Test Card 10135 and 3M™ Attest™ eBowie-Dick Card Holder 10135CH is designed for testing air removal efficiency of 132°C (270°F), 134°C (273°F), and 135°C (275°F) for 3.5 minute test cycles in dynamic-air-removal steam sterilizers with chamber volumes greater than 54L (approximately 2 cubic feet). 3M™ Attest eBowie-Dick Auto-reader The 3M™ Attest™ eBowie-Dick Auto-reader is designed to automatically interpret, store, and display the result of the 3M™ Attest™ eBowie-Dick Test Card.

Source page: https://510kreport.com/device/DEN230068
Methodology: https://510kreport.com/methodology