# K971627: Silicone Antibacterial Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rochester Medical Corp.
- Decided: Jan 13, 1998 after 256 days
- Product code: MJC (Catheter, Urological (Antimicrobial) And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871429 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910318: Bard (R) Hydrogel/Silver-Coated Foley Catheter, C.R. Bard, Inc. (1994) Summary page 1.
- K871429: Antimicrobial Foley Catheter, American Pharmaseal Div. Ahsc (1987) Summary page 1.
- K896053: All Silicone Foley Catheter, Rochester Medical Corp. (1990) Summary page 1.

## Indications for use
The Silicone Antibacterial Foley catheter is intended for short term use to provide continuous urinary bladder drainage in adult males and females requiring catheterization for surgical procedures, monitoring urine output, management of incontinence, and voiding dysfunction. The catheter has been shown to provide a statistically significant reduction in the incidence of catheter acquired bacterial urinary tract infection during the first 5 days of catheterization. This device is not intended to be used as a treatment for active urinary tract infections.

Source page: https://510kreport.com/device/K971627
Methodology: https://510kreport.com/methodology