# K030004: 0.55% Orth-Phthalaldehyde Solution

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Feb 27, 2003 after 56 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991487 (1999). 1 ancestor in all.
6 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)
- K991487: Cidex Opa Solution, Advanced Sterilization Products (1999) Summary page 1.

## Most influential descendants
- K070627: Opaciden Solution (2007), 5 descendants of its own
- 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

## Recalls of this device
- Aug 10, 2015 · Class II · Z-2774-2015: Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of 
- Jun 1, 2012 · Class II · Z-2276-2012: The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012.

## Indications for use
CIDEX@OPA Solution is a high level disinfectant for reprocessing heat sensitive medical devices, for which sterilization is not suitable, and when used according to the Directions for Use. Manual Processing: High Level Disinfectant at a minimum of 20°C (68°F): 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, with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days. Automatic Endoscope Reprocessors that can be set to 25°C: High Level Disinfectant at a minimum of 25°C (77°F): CIDEX@OPA Solution is a high level disinfectant when used or reused in a legally marketed automatic endoscope reprocessor (that can be set to 25°C) according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX@ OPA Solution Test Strips, with an immersion time of at least 5 minutes for a reuse period not to exceed 14 days. Minimum Effective Concentration (MEC): 0.3%. Note: If your AER cannot be set to a minimum of 25°C please follow the time and temperature stated in Indications for Use, Manual Processing.

Source page: https://510kreport.com/device/K030004
Methodology: https://510kreport.com/methodology