# K953122: Steritec Dry Heat Indicator Label

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Apr 2, 1997 after 637 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.
No later device cites it as a predicate yet.
0 of 1 device 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 Dry Heat Indicator Labels: named in the summary without a submission number

## Indications for use
SteriTec Dry Heat Indicator Labels are designed to be utilized in dry heat (hot air) sterilizers operating at 160 C. The label provides clear identification of processed versus unprocessed items.

Source page: https://510kreport.com/device/K953122
Methodology: https://510kreport.com/methodology