# K991487: Cidex Opa Solution

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Oct 8, 1999 after 163 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
No predicates in its family tree.
25 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CIDEX® Activated Dialdehyde Solution: named in the summary without a submission number
- (no number) Peract 20: named in the summary without a submission number

## Most influential descendants
- K040883: Evotech Integrated Endoscope Disinfection System (2005), 18 descendants of its own
- K061899: Evotech Integrated Endoscope Disinfection System (2006), 17 descendants of its own
- K082988: Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant (2009), 7 descendants of its own
- K030004: 0.55% Orth-Phthalaldehyde Solution (2003), 6 descendants of its own
- K070627: Opaciden Solution (2007), 5 descendants of its own

## Indications for use
CIDEX® OPA Solution is a high level disinfectant for reprocessing heat sensitive medical devices, and when used according to the Directions for Use. High Level Disinfectant: CIDEX® OPA Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX® OPA Solution Test Strips, at 20° C (68° F) with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days. Minimum Effective Concentration (MEC): 0.3%.

Source page: https://510kreport.com/device/K991487
Methodology: https://510kreport.com/methodology