# K971259: Combiport Fluid Lavage Device

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Oct 27, 1997 after 206 days
- Product code: KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration)
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 K951533 (1995). 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)
- K951533: Easi-Lav Pediatric / Adult Gastric Lavage Kit, Ballard Medical Products (1995) Summary page 1.

## Indications for use
CombiPort Fluid Lavage Device is intended to flush fluid into the stomach during gastric lavage procedures.

Source page: https://510kreport.com/device/K971259
Methodology: https://510kreport.com/methodology