# K060618: Cidex Activated Dialdehyde Solution

- Pathway: 510(k) (Special)
- Applicant: Johnson & Johnson Co.
- Decided: Apr 12, 2006 after 35 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924434 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924434: Cidex Activated Dialdehyde Solution, Johnson & Johnson Medical, Inc. (1994) Summary page 1.

## Recalls of this device
- Jul 27, 2015 · Class II · Z-2459-2015: Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.

## Indications for use
CIDEX® Activated Dialdehyde Solution is a liquid chemical sterilant and a high level disinfectant for reprocessing heat sensitive medical/dental devices such as endoscopes, respiratory therapy equipment and ultrasonic transducers. Sterilant: CIDEX Solution is a sterilant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by the CIDEX® Solution Test Strip, at 25°C (770) with an immersion time of at least 10 hours with a reuse period not to exceed 14 days. High Level Disinfectant: CIDEX 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 the CIDEX® Solution Test Strip, at 250 C (770) with an immersion time of at least 45 minutes with a reuse period not to exceed 14 days. CIDEX Solution is intended for use in manual systems as well as in automated endoscope reprocessors.

Source page: https://510kreport.com/device/K060618
Methodology: https://510kreport.com/methodology