# K023716: Spsmedical Sporview Bacterial Spore Strip

- Pathway: 510(k) (Special)
- Applicant: Spsmedical Supply Corp.
- Decided: Dec 5, 2002 after 30 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: 1 generation back to K905425 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K041099: Modification to Spsmedical Sporview Bacterial Spore Strip (2004), 0 descendants of its own

## 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 SporViewQ Bacterial Spore Strip is designed to monitor steam sterilizer cycles at 121°C and 132°C. The combination of SPSmedical’s spore strip and SporViewB Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple) has been validated at 60°C for a reduced incubation time of 24 hours for steam sterilization processes.

Source page: https://510kreport.com/device/K023716
Methodology: https://510kreport.com/methodology