# K010607: Med-RX Irrigation Set, Model 10-3001, 10-3002, 10-4000, 10-4001

- Pathway: 510(k) (Traditional)
- Applicant: Benlan, Inc.
- Decided: Nov 28, 2001 after 272 days
- Product code: LJH (System, Irrigation, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Aug 19, 2022 · Class III · Z-0202-2023: Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.

Source page: https://510kreport.com/device/K010607
Methodology: https://510kreport.com/methodology