# K771080: Steam Sterilization Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Info-Chem
- Decided: Jul 14, 1977 after 29 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
- K101249: Sterigage Model 1243RA, 1243RB, 1243RE (2010), 4 descendants of its own
- K191236: 3M™ Attest™ Steam Chemical Integrators (2019), 3 descendants of its own
- K193254: 3M Attest Steam Chemical Integrator (2019), 2 descendants of its own
- K220942: 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) (2022), 1 descendant of its own
- K261992: 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K771080
Methodology: https://510kreport.com/methodology