# K041360: Aldahol Iii High-Level Disinfectant

- Pathway: 510(k) (Traditional)
- Applicant: Healthpoint, Ltd.
- Decided: May 5, 2005 after 349 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cidex Activated Dialdehyde Solution: named in the summary without a submission number

## Most influential descendants
- K113015: Aldahol V High Level Disinfectant (2012), 0 descendants of its own
- K091890: Extended Use Aldahol High Level Disinfectant (2010), 0 descendants of its own

## Indications for use
Sterilization: Aldahol III High-Level Disinfectant is a sterilant intended for the sterilization of reusable, clean, heat-sensitive medical devices when used as directed at or above its minimum recommended concentrations (MRC) of 2.1% alkaline glutaraldehyde and 15.0% isopropanol with an exposure of 10.0 hrs at 20 C. High-Level Disinfection: Aldahol III High-Level Disinfectant is a high-level disinfectant intended for the disinfection of reusable, clean, heat-sensitive medical devices when used as directed at or above its MRC of 2.1% alkaline glutaraldehyde and 15.0% isopropanol with an exposure of 10.0 min at 20 C.

Source page: https://510kreport.com/device/K041360
Methodology: https://510kreport.com/methodology