# K012889: Banicide Liquid Chemical Sterilant/High-Level Disinfectant

- Pathway: 510(k) (Traditional)
- Applicant: Pascal Co., Inc.
- Decided: May 27, 2003 after 637 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
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) Wavicide 01: named in the summary without a submission number
- (no number) Cidex Plus 28-day Solution: named in the summary without a submission number
- (no number) MetriCide 28 day Long-Life Activated Dialdehyde solution: named in the summary without a submission number

## Recalls of this device
- Aug 9, 2005 · Not classified · Z-1588-05: The product, Banicide Advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.

## Indications for use
Banicide@Advanced is a reusable liquid chemical sterilant/high level disinfectant intended to (1) sterilize medical instruments at an exposure time of 10 hours and an exposure temperature of 25°C and a minimum effective concentration of 1.8% glutaraldehyde; and (2) provide high level disinfection at an exposure time of 45 minutes and an exposure temperature of 25°C and a minimum effective concentration of 1.8% glutaraldehyde. It may be re-used for a period of 30 days provided the solution remains above the MEC as confirmed by a chemical indicator test strip.

Source page: https://510kreport.com/device/K012889
Methodology: https://510kreport.com/methodology