# K192445: QwikCheck Chemical Indicators

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corporation
- Decided: Apr 2, 2020 after 209 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 K910320 (1991). 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)
- K910320: Serim Peracetic Acid Reagent Strips, Serim Research Corp. (1991) Summary page 4.

## Indications for use
The QwikCheck™ Chemical Indicator is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in CS Medical’s TD-12 Solution, is above or below the manufacturer’s established Minimum Recommended Concentration (MRC) of 1750 ppm.

Source page: https://510kreport.com/device/K192445
Methodology: https://510kreport.com/methodology