# K770789: Uri-Drain Combo Kit for Male Incontinenc

- Pathway: 510(k) (Traditional)
- Applicant: Chesebrough-Pond'S U.S.A. Co.
- Decided: Oct 18, 1977 after 168 days
- Product code: KNX (Collector, Urine, (And Accessories) For Indwelling Catheter)
- Device class: 2
- Regulation: 21 CFR 876.5250
- Recalls of this device: 3 (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
- Apr 29, 2011 · Not classified · Z-2393-2011: A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination
- Apr 29, 2011 · Not classified · Z-2394-2011: A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination
- Apr 29, 2011 · Not classified · Z-2392-2011: A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination

Source page: https://510kreport.com/device/K770789
Methodology: https://510kreport.com/methodology