# K971992: Uromed Alternative Bladder Control Continence Device (Abcpn-0026)

- Pathway: 510(k) (Traditional)
- Applicant: Uromed Corp.
- Decided: Aug 1, 1997 after 64 days
- Product code: FHA (Clamp, Penile)
- Device class: 1
- Regulation: 21 CFR 876.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954959 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964580: Cap-Aid (Improved), Nebel, Inc. (1997) Summary page 1.
- K885323: Dacomed External Male Continence Device, Dacomed Corp. (1989) Summary page 1.
- K952841: The Assistant, Apple Medical Corp. (1995) Summary page 1.
- (no number) Cunningham Clamp: named in the summary without a submission number

## Indications for use
The UroMed ABC device is indicated to prevent or reduce episodes of male urinary incontinence.

Source page: https://510kreport.com/device/K971992
Methodology: https://510kreport.com/methodology