# K254111: Irrigation/Urology Sets

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Sep 10, 2026 after 265 days
- Product code: LJH (System, Irrigation, Urological)
- 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 K960787 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960787: Tur,Arthroscopic,Cystoscopy Irrigation Sets, Baxter Healthcare Corp (1996) Summary page 5.

## Indications for use
B. Braun Medical Irrigation Tubing Set is intended for delivery of irrigation solutions from a container to an irrigation site during bladder irrigation or endoscopic procedures such as cystoscopy and transurethral resection procedures.

Source page: https://510kreport.com/device/K254111
Methodology: https://510kreport.com/methodology