# K041984: Acecide High-Level Disinfectant and Sterilant

- Pathway: 510(k) (Traditional)
- Applicant: Best Sanitizers, Inc.
- Decided: May 11, 2005 after 292 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 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) Minntech Peract® 20 Liquid Sterilant/Disinfectant: named in the summary without a submission number
- (no number) Medivators Rapicide™ High Level Disinfectant and Sterilant: named in the summary without a submission number

## Most influential descendants
- K082988: Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant (2009), 7 descendants of its own
- K152394: Rapicide PA High-Level Disinfectant Test Strips (2016), 2 descendants of its own
- K192228: CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant (2020), 1 descendant of its own
- K251035: DISINTEK™ PA Test Strips (2025), 0 descendants of its own
- K251048: Rapicide PA High-Level Disinfection Test Strip  Model Ref # = ML02-0118 (2025), 0 descendants of its own

## Indications for use
Acecide High-Level Disinfectant and Sterilant is intended to be used for the automated sterilization or high-level disinfection of clean, heat sensitive, critical or semi-critical medical devices that are not compatible with other sterilization or high-level disinfection processes that can be biologically monitored. Acecide High-Level Disinfectant and Sterilant should be used under the following contact conditions: Sterilization: 5 hours, 25°C, 1900 ppm peracetic acid High-Level Disinfection: 5 minutes, 25°C, 1900 ppm peracetic acid Acecide Peracetic Acid Test Strips are intended for verifying the minimum recommended concentration of peracetic acid in Acecide High-Level Disinfectant and Sterilant during reuse.

Source page: https://510kreport.com/device/K041984
Methodology: https://510kreport.com/methodology