# K110369: Indistrip Green

- Pathway: 510(k) (Traditional)
- Applicant: Indilab, Inc.
- Decided: May 6, 2011 after 87 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 K875193 (1988). 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)
- K875193: Indistrip (Sterilization Process Indicator), Indilab, Inc. (1988) Summary page 1.

## Indications for use
For use as an internal or external chemical indicator to monitor exposure to steam sterilization conditions for: 12100 (250'F) @ 30 minutes in gravity steam sterilizer cycles or @ 1340C (273 0F) for 4 minutes in gravity or vacuum assisted steam sterilizer cycles.

Source page: https://510kreport.com/device/K110369
Methodology: https://510kreport.com/methodology