# K970946: Medline Y-Type Tur/Bladder Irrigation Set

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jun 10, 1997 after 88 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 K934382 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934382: Vci Suction/Irrigation Tubing Set, Vital Concepts, Inc. (1994) Summary page 1.
- (no number) Baxter Healthcare’s Y-Type TUR/Bladder Irrigation Set: named in the summary without a submission number

## Most influential descendants
- K070873: Amsure Bladder Irrigation Set (2007), 0 descendants of its own

## Indications for use
Medline Y-Type TUR/Bladder Irrigation Set is Intended for the infusion of sterile solutions into the bladder to cleanse (evacuate) the contents of the bladder. It is also indicated for use in transurethral resection (prostrate or bladder surgery) as a means of continuous irrigation of the bladder It is intended to be used with sterile solutions only. Not intended for reuse.

Source page: https://510kreport.com/device/K970946
Methodology: https://510kreport.com/methodology