# K960503: Dantec Duet

- Pathway: 510(k) (Traditional)
- Applicant: Dantec Medical, Inc.
- Decided: Sep 16, 1996 after 227 days
- Product code: FEN (Device, Cystometric, Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.1620
- 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 K860571 (1986). 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)
- K912701: Dantec Menuet, Dantec Medical, Inc. (1991) Summary page 1.
- K904386: Urolab Janus, Life-Tech Intl., Inc. (1990) Summary page 1.
- K860571: F.M. Weist,KG (Urodynamic Systems), F.M. Wiest USA, Inc. (1986) Summary page 1.
- K924383: Synectics Liberty System, PC Polygraf/Polygram Uro, Synectics-Dantec (1993) Summary page 1.

## Indications for use
General indications for use include use in patients with lower urinary tract voiding or continence problems, and more specifically incontinent patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction and some children with complex voiding / incontinence problems.

Source page: https://510kreport.com/device/K960503
Methodology: https://510kreport.com/methodology