# K070627: Opaciden Solution

- Pathway: 510(k) (Traditional)
- Applicant: Ciden Technologies, LLC
- Decided: Aug 2, 2007 after 149 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: 2 generations back to K991487 (1999). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030004: 0.55% Orth-Phthalaldehyde Solution, Advanced Sterilization Products (2003) Summary page 1.

## Most influential descendants
- K120306: Rapicide Opa-28 (2012), 3 descendants of its own
- K160921: CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant (2016), 2 descendants of its own
- K192228: CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant (2020), 1 descendant of its own
- K233049: TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator (2023), 0 descendants of its own
- K140703: Opa 30 Solution (2014), 0 descendants of its own

## Indications for use
Opaciden 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. Opaciden 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 200 C (680 F), for a reuse period not to exceed 14 days. Opaciden may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 250 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 250 C (770 F), for a reuse period not to exceed 14 days.

Source page: https://510kreport.com/device/K070627
Methodology: https://510kreport.com/methodology