# K982151: Steritite Process Indicator Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Case Medical, Inc.
- Decided: Feb 9, 1999 after 236 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Process indicators are intended for the use with individual units, to demonstrate that the unit has been exposed to a process at stated conditions and distinguish between processed and unprocessed units at stated conditions.

Source page: https://510kreport.com/device/K982151
Methodology: https://510kreport.com/methodology