# K983947: Amerse 2

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Dec 4, 1998 after 29 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 its predicate without a number.
- (no number) Bulk Lysol® Brand Disinfectant: named in the summary without a submission number
- (no number) LF-10 Hospital Disinfectant Concentrate, Reckitt & Coleman: named in the summary without a submission number
- (no number) Micro Bac Phenolic Detergent Disinfectant, Ecolabs: named in the summary without a submission number
- (no number) Sporicidin Brand Disinfectant Solution, Sporicidin International: named in the summary without a submission number

## Indications for use
Amerse 2 is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preclean or decontaminate critical or semi-critical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.

Source page: https://510kreport.com/device/K983947
Methodology: https://510kreport.com/methodology