# K041099: Modification to Spsmedical Sporview Bacterial Spore Strip

- Pathway: 510(k) (Special)
- Applicant: Spsmedical Supply Corp.
- Decided: May 6, 2004 after 10 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905425 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023716: Spsmedical Sporview Bacterial Spore Strip, Spsmedical Supply Corp. (2002) Summary page 1.
- K905425: Sporview, Spsmedical Supply Corp. (1992) Summary page 1.

## Recalls of this device
- Dec 11, 2024 · Class II · Z-1141-2025: Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the

## Indications for use
The SPSmedical SporView® Bacterial Spore Strip is designed to monitor Chemiclave® chemical vapor sterilizers. The combination of SPSmedical's spore strip and SporView® Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple) has been validated at 60°C for a reduced incubation time of 72 hours for the Chemiclave® chemical vapor sterilization process.

Source page: https://510kreport.com/device/K041099
Methodology: https://510kreport.com/methodology