# K202565: WAVICIDE-OPA MEC Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corporation
- Decided: Dec 2, 2020 after 89 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: 3 generations back to K922481 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081370: Serim Disintek Opa Test Strip, Serim Research Corp. (2008) Summary page 4.

## Indications for use
The WAVICIDE-OPA® MEC Indicator is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in the high-level disinfectant WAVICIDE-OPA® Solution, is above or below the minimum effective concentration (MEC) established for WAVICIDE-OPA Solution.

Source page: https://510kreport.com/device/K202565
Methodology: https://510kreport.com/methodology