# K192577: Actreen Hi-Lite Intermittent Urinary Catheters

- Pathway: 510(k) (Special)
- Applicant: B.Braun Medical, Inc.
- Decided: May 7, 2020 after 231 days
- Product code: GBM (Catheter, Urethral)
- 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: 7 generations back to K910022 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180801: Actreen Hi-Lite Cath, Actreen Hi-Lite Set, B.Braun Medical, Inc. (2018) Summary page 4.

## Indications for use
Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.

Source page: https://510kreport.com/device/K192577
Methodology: https://510kreport.com/methodology