# K032723: Biosign Steam-24 Biological Indicator

- Pathway: 510(k) (Special)
- Applicant: Getinge USA, Inc.
- Decided: Oct 1, 2003 after 28 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: 1 generation back to K872867 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872867: Biosign, Clinical Technology Corp. (1988) Summary page 1.

## Indications for use
The Gelinge Biosign Steam-24 Biological Indicator is a steam sterilization monitor designed specifically for biological testing of 121”C, 134‘ C gravity and pre-vacuurn and flash gravity and pre-vacuum steam sterilization cycle.; with results available after 24 hours incubation.

Source page: https://510kreport.com/device/K032723
Methodology: https://510kreport.com/methodology