# K971271: Besecure External Urinary Collection System

- Pathway: 510(k) (Traditional)
- Applicant: Urology Research Intl., Inc.
- Decided: Aug 18, 1997 after 136 days
- Product code: KNX (Collector, Urine, (And Accessories) For Indwelling Catheter)
- Device class: 2
- Regulation: 21 CFR 876.5250
- 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 BeSECURE External Urinary Collection System is an external urine collection system for the incontinent patient.

Source page: https://510kreport.com/device/K971271
Methodology: https://510kreport.com/methodology