# K964580: Cap-Aid (Improved)

- Pathway: 510(k) (Traditional)
- Applicant: Nebel, Inc.
- Decided: Jan 10, 1997 after 56 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: 1 generation back to K954959 (1995). 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)
- K954959: Cap-Aid, Nebl, Inc. (1995) Summary page 2.

## Most influential descendants
- K971992: Uromed Alternative Bladder Control Continence Device (Abcpn-0026) (1997), 0 descendants of its own

## Indications for use
The product prevents urinary leakage in men with urinary incontinence.

Source page: https://510kreport.com/device/K964580
Methodology: https://510kreport.com/methodology