# K043135: Spsmedical Sporview PA Culture Set

- Pathway: 510(k) (Traditional)
- Applicant: Spsmedical Supply Corp.
- Decided: Jan 13, 2005 after 62 days
- Product code: MRB (Indicator, Biological, Liquid Chemical 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: 3 generations back to K792649 (1980). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020205: Castle Peracetic Acid Biological Indicator Kit, Getinge/Castle, Inc. (2002) Summary page 1.

## Most influential descendants
- K081879: Spsmedical Sporview PA Culture Set (2008), 0 descendants of its own

## Indications for use
The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The STERIS System 1® is a liquid chemical sterilization process. The SporView® PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 1® processing cycle. A reduced incubation time of 24 hours has been validated for the SporView® PA Culture Set using SPSmedical's SporView® culture media.

Source page: https://510kreport.com/device/K043135
Methodology: https://510kreport.com/methodology