# K962441: Prospore (Stearo for Steam Sterilizer)

- Pathway: 510(k) (Traditional)
- Applicant: Raven Biological Laboratories, Inc.
- Decided: Sep 18, 1996 after 86 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 K905425 (1992). 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)
- K905425: Sporview, Spsmedical Supply Corp. (1992) Summary page 1.
- (no number) Kilt™ (BBL): named in the summary without a submission number

## Indications for use
ProSpore® is a self-contained biological indicator used for determining the efficiency of a 121°C steam sterilization cycle.

Source page: https://510kreport.com/device/K962441
Methodology: https://510kreport.com/methodology