# K031681: Sterisil Antimicrobial Tubing and Bottle

- Pathway: 510(k) (Traditional)
- Applicant: Sterisil
- Decided: Oct 30, 2003 after 153 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The treated article controls the growth of bacteria, fungus, and algae providing the antimicrobial surface is regenerated with the continuous use of a Sterisil water pretreatment product. The Sterisil treated article is intended to be used with distilled, deionized, or reverse osmosis water. Efficacy for tap water has not been determined. This product is not intended to provide sterile water.

Source page: https://510kreport.com/device/K031681
Methodology: https://510kreport.com/methodology