# K233681: ConFirm 20 Minute Incubator

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Dec 15, 2023 after 29 days
- Product code: FRC (Indicator, Biological 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
Longest line of descent: 6 generations back to K004009 (2002). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223715: Celerity Incubator, STERIS Corporation (2023) Summary page 6.

## Indications for use
Use the ConFirm 20 Minute Incubator to incubate and automatically read ConFirm Rapid 20 Minute Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.

Source page: https://510kreport.com/device/K233681
Methodology: https://510kreport.com/methodology