# K981023: Kleenaseptic

- Pathway: 510(k) (Traditional)
- Applicant: Metrex Research Corp.
- Decided: Apr 30, 1998 after 42 days
- Product code: LRJ (Disinfectant, Medical Devices)
- Device class: 1
- Regulation: 21 CFR 880.6890
- 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 no predicate by number.

## Indications for use
Kleenaseptic is a ready-to-use, spray-on general purpose disinfectant intended for use in cleaning and disinfecting equipment sarfaces and non-critical devices in hospitals and other critical care areas where environmental control of cross contamination is important. Kleenaseptic is a disinfectant when used on equipment surfaces and non-critical devices for 10 minutes at room temperature (69°F/20°C).

Source page: https://510kreport.com/device/K981023
Methodology: https://510kreport.com/methodology