# K960441: Steritec Integraph Model CI-101

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: May 8, 1997 after 462 days
- Product code: JOJ (Indicator, Physical/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
No predicates in its family tree.
6 later devices descend from it; 3 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) ATI Steam C.I.: named in the summary without a submission number

## Most influential descendants
- K070461: Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4 (2007), 3 descendants of its own
- K071895: Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator (2007), 2 descendants of its own
- K083643: Verify 275F Gravity Indicators (2009), 1 descendant of its own
- K182724: CelerityTM 10 STEAM Chemical Indicator (2018), 0 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

## Indications for use
The Steritec Integraph is designed to provide an integrated response to steam sterilization at 132 C for sterilizers operating for 3 1/2 minutes or longer.

Source page: https://510kreport.com/device/K960441
Methodology: https://510kreport.com/methodology