# K222137: OK Plus Indicator

- Pathway: 510(k) (Abbreviated)
- Applicant: Propper Manufacturing Co., Inc.
- Decided: Dec 5, 2022 after 139 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 K191021 (2019). 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)
- K191021: Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye, Terragene S.A. (2019) Summary page 5.

## Indications for use
The OK Plus indicator is a chemical indicator designed for monitoring the efficacy of steam sterilization process. The indicator responds to all critical sterilization parameters. The OK Plus indicator changes color from off-white to black to indicate that the conditions of the cycle have been met. The indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: *Gravity: 121 C/250 F - 30 minutes *Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes *Vacuum assisted (prevacuum): 132 C/270 F - 10 minutes *Vacuum assisted (prevacuum): 134 C/273 F - 3.5 minutes *Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes *Vacuum assisted (prevacuum): 135 C/275 F - 3 minutes The OK Plus indicator has the following Stated Values determined in Resistometer: * 121 C/250 F - 15 minutes * 132 C/270 F - 4 minutes * 134 C/273 F - 3 minutes * 135 C/275 F - 2.9 minutes

Source page: https://510kreport.com/device/K222137
Methodology: https://510kreport.com/methodology