# K113015: Aldahol V High Level Disinfectant

- Pathway: 510(k) (Traditional)
- Applicant: Microchem Laboratories, Inc.
- Decided: Jan 30, 2012 after 111 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: 1 generation back to K041360 (2005). 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)
- K041360: Aldahol Iii High-Level Disinfectant, Healthpoint, Ltd. (2005) Summary page 2.

## Indications for use
Aldahol® V High Level Disinfectant is intended for the high level disinfection of reusable, clean, heat-sensitive, semi-critical medical devices which contact intact mucous membranes when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 10.0 min at 20°C. Aldahol V High Level Disinfectant is intended for the sterilization of reusable, clean, heat-sensitive critical and semi-critical medical devices which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization available with a biological indicator, when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldehyde for 8.0 hrs at 20°C. Aldahol V High Level Disinfectant may be used in a legally marketed, validated, automatic endoscope reprocessor machine or in a manual bucket system.

Source page: https://510kreport.com/device/K113015
Methodology: https://510kreport.com/methodology