# K894399: Sterigage Integrator Test Pack for Steam Sterili.

- Pathway: 510(k) (Traditional)
- Applicant: Pymah Corp.
- Decided: Sep 11, 1989 after 56 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K071895: Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator (2007), 2 descendants of its own
- K162758: VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack (2017), 0 descendants of its own
- K102894: Classix Chemical Sterilization Indicator (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K894399
Methodology: https://510kreport.com/methodology