# K974188: Cetylcide-G

- Pathway: 510(k) (Traditional)
- Applicant: Kellerandheckman
- Decided: Sep 10, 1998 after 307 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.
No later device cites it as a predicate yet.
0 of 1 device 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 Plus 28-day Solution: named in the summary without a submission number
- (no number) MetriCide 28 day Long-Life Activated Dialdehyde Solution: named in the summary without a submission number

## Indications for use
Cetylcide-G is a liquid chemical sterilant-high level disinfectant intended for use on medical devices. For use as a sterilant, immerse instruments in Cetylcide-G Use Solution for 10 hours at 20°C. For use as a high-level disinfectant, immerse instruments in Cetylcide-G Use Solution for 40 minutes at 20°C.

Source page: https://510kreport.com/device/K974188
Methodology: https://510kreport.com/methodology