# K971432: Prospore

- Pathway: 510(k) (Traditional)
- Applicant: Raven Biological Laboratories, Inc.
- Decided: May 20, 1997 after 33 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 3 (0 Class I)
- 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). Our OCR of the scanned summary read K805425, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SporView™ (SPSmedical)”.
- (no number) Kilit™ (BBL): named in the summary without a submission number

## Recalls of this device
- Feb 12, 2018 · Class II · Z-1274-2018: The concentration of bromocresol purple in the recalled lots does not conform to specification.
- Feb 12, 2018 · Class II · Z-1273-2018: The concentration of bromocresol purple in the recalled lots does not conform to specification.
- Apr 4, 2016 · Class II · Z-1104-2017: Product resistance has fallen outside of label claim within expiry.

## Indications for use
ProSpore® is-a biological sterifization process indicator for steam sterilization at 121°C is a device intended for use by a health care provider to accompany products being sterilized through a steam sterilization procedure and to monitor adequacy of sterilization.

Source page: https://510kreport.com/device/K971432
Methodology: https://510kreport.com/methodology