# K982547: Steritec Cross-Checks EO Gas Sterilization Integrator

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Oct 8, 1998 after 79 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
Longest line of descent: 1 generation back to K800029 (1980). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800029: Surgicot 2 Indicator System, Surgicot, Inc. (1980) Summary page 2.

## Cited in the summary but kept off the family tree
- K800029A: SURGICOT 2 EO Gas Indicator Strip. Number could not be read Summary page 2.

## Indications for use
Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers. Color change to brown is complete between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.

Source page: https://510kreport.com/device/K982547
Methodology: https://510kreport.com/methodology