# K965212: Steritec Disposable Integrator Load Challenge-Steam

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Apr 23, 1998 after 482 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 K952408 (1995). 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)
- K952408: Ati Disposable Test Pack for Steam Sterilization, Pymah Corp. (1995) Summary page 2.

## Indications for use
The SteriTec Chemical Integrator Challenge Pack-Steam is designed Lo be used 1o monitor sterilization cycles in pre-vacuum steam sterilizers operating at 132 °C. lor 3 minutes or Ionger It is to be used as a supplementary test to biological pack lesting. nol as a substitute.

Source page: https://510kreport.com/device/K965212
Methodology: https://510kreport.com/methodology