# K800482: Stearothermohilus Spore Strips

- Pathway: 510(k) (Traditional)
- Applicant: Mdt Corp., Inc.
- Decided: Apr 16, 1980 after 43 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960777: MDT Unispore and Spor-Test Biologicalindicator (1996), 4 descendants of its own
- K020205: Castle Peracetic Acid Biological Indicator Kit (2002), 3 descendants of its own
- K043135: Spsmedical Sporview PA Culture Set (2005), 1 descendant of its own
- K081879: Spsmedical Sporview PA Culture Set (2008), 0 descendants of its own
- K050664: Spor-Test PA Biological Indicator Kit (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K800482
Methodology: https://510kreport.com/methodology