# K120306: Rapicide Opa-28

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Sep 27, 2012 after 239 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). 4 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K070627: Opaciden Solution, Ciden Technologies, LLC (2007) Summary page 2.
- K030004: 0.55% Orth-Phthalaldehyde Solution, Advanced Sterilization Products (2003) Summary page 2.
- K993042: Medivators 5 Minute High-Level Disinfectant, Medivators, Inc. (2000) Summary page 2.

## Most influential descendants
- 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

## Indications for use
Rapicide OPA-28 is a high level disinfectant solution for reprocessing of heat sensitive semi-critical medical devices for which sterilization is not suitable. Rapicide OPA-28 may be used at or above its minimum recommended concentration (MRC) of 0.35% OPA as determined by Rapicide OPA-28 test strips in manual device reprocessing with an immersion time of at least 10 minutes at a minimum temperature of 20°C for a reuse period not to exceed 28 days. Rapicide OPA-28 may also be used in compatible legally marketed automatic endoscope reprocessors at or above its MRC as determined by Rapicide OPA-28 test strips with an immersion time of at least 5 minutes at a minimum temperature of 25°C for a reuse period not to exceed 28 days.

Source page: https://510kreport.com/device/K120306
Methodology: https://510kreport.com/methodology