# K032959: Cidex Opa Concentrate

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Apr 4, 2005 after 559 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- 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 K875280 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991487: Cidex Opa Solution, Advanced Sterilization Products (1999) Summary page 1.
- K875280: Steris System 1 Processor and 20 Sterilant, Steris C/O Medical Device Consultants, Inc. (1988) Summary page 1.

## Indications for use
CIDEX® OPA Concentrate is a high level disinfectant (HLD) at the minimum IN USE concentration of 0.055% with a contact time of 5 minutes at 50°C for reprocessing heat sensitive (<60°C) semi-critical endoscopes when used according to the Directions for Use. CIDEX® OPA Concentrate is intended for use in the ASP EvoTech™ System. THIS PRODUCT IS NOT INTENDED FOR MANUAL USE. See Directions for Use.

Source page: https://510kreport.com/device/K032959
Methodology: https://510kreport.com/methodology