# K140703: Opa 30 Solution

- Pathway: 510(k) (Traditional)
- Applicant: Ciden Technologies, LLC
- Decided: Aug 19, 2014 after 152 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: 3 generations back to K991487 (1999). 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)
- K070627: Opaciden Solution, Ciden Technologies, LLC (2007) Summary page 4.

## Indications for use
OPA 30 Solution is a high level disinfectant for reprocessing heat sensitive semi-critical medical devices for which sterilization is not suitable, and when used according to the Directions for Use. OPA 30 Solution may be used or reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20°C (68°F), for a reuse period not to exceed 30 days. OPA 30 Solution may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25°C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25°C (77°F), for a reuse period not to exceed 14 days.

Source page: https://510kreport.com/device/K140703
Methodology: https://510kreport.com/methodology