# K091890: Extended Use Aldahol High Level Disinfectant

- Pathway: 510(k) (Traditional)
- Applicant: Healthpoint, Ltd.
- Decided: Mar 24, 2010 after 274 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 1.

## Indications for use
Extended Use Aldahol 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 5.0 min at 250 C in an automated endoscope reprocessor with FDA-cleared capability to maintain the exposure of 5.0 min at 250 C. Extended Use Aldahol 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, when the disinfectant is used at or above its minimum recommended concentration of 1.8% glutaraldlehyde for 6.0 hrs at 250 C.

Source page: https://510kreport.com/device/K091890
Methodology: https://510kreport.com/methodology