# K091210: Acecide-C High Level Disinfectant and Sterilant

- Pathway: 510(k) (Traditional)
- Applicant: Best Sanitizers, Inc.
- Decided: Feb 5, 2010 after 287 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041984 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041984: Acecide High-Level Disinfectant and Sterilant, Best Sanitizers, Inc. (2005) Summary page 1.

## Recalls of this device
- Aug 2, 2016 · Class II · Z-2714-2016: Certain lots of the acid solution in Acecide-C are degrading faster than normal.

## Indications for use
ACECIDE-C is a high level disinfectant intended to disinfect reusable clean heat-sensitive semi-critical medical devices (such as flexible endloscopes) which contact mucous membranes when used at or above its minimum recommended concentration of 2000 ppm peracetic acid for 7.0 minutes at 200C. ACECIDE-C is a sterilant intended to sterilize reusable clean heat-sensitive critical and semi-critical medical devices (such as flexible endloscopes) which contact and potentially penetrate into sterile body areas, for which there is no other practical method of sterilization, when used at or above its minimum recbmmended concentration of 2000 ppm peracetic acid for 2.0 hours at 200 C. ACECIDE Test Strips are used with ACECIE-C High Level Disinfectant and Sterilant use solution to ensure that the level of peracetic acid is above the minimum recommended concentration of 2000 ppm.

Source page: https://510kreport.com/device/K091210
Methodology: https://510kreport.com/methodology