# K983585: Low PH Phenolic 256

- Pathway: 510(k) (Traditional)
- Applicant: Central Solutions, Inc.
- Decided: Nov 6, 1998 after 24 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
For use in health care settings for low and intermediate level disinfection of hard, non-porous, inanimate surfaces of wheelchairs, medical beds, patient transfer lifts, crutches, instrument trays, operating tables, stethoscopes, bedpans, blood donor chairs, dental chairs, medical lamps, whirlpool bathing units, and other medical devices that require low or intermediate level disinfection. This product may be used to preclean or decontaminate critical or non-critical medical devices prior to sterilization or high-level disinfection. The effectiveness of this product has been documented at a temperature of 88°F (20°C), with a ten minute contact time on the surface being treated.

Source page: https://510kreport.com/device/K983585
Methodology: https://510kreport.com/methodology