510(k) · Cleared
ClearedDantec Duet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dantec Medical, Inc. · FEN Device, Cystometric, Hydraulic
Cleared on Sep 16, 1996 as substantially equivalent to K912701 (Dantec Medical, Inc., 1991) and 3 other predicates after a 227-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Sep 16, 1996
- Review
- 227 days
- Class
- Class II
- Product code
- FEN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K860571 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK860571 F.M. Weist,KG (Urodynamic Systems)F.M. Wiest USA, Inc. · 1986
- This deviceK960503 Dantec DuetDantec Medical, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860571 | F.M. Weist,KG (Urodynamic Systems) | F.M. Wiest USA, Inc. | 1986 | — |
| 0 (this device) | K960503 | Dantec Duet | Dantec Medical, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FEN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FEN device
- #1 K212830 CT3000Proscore 2.9 · 2 generations · no Class I recall
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K912701 | Dantec MenuetSummary page 1…Name: Dantec Duet™ Common/Usual Name: Urodynamics System Classification Name: Urodynamics Measurement System Predicate Device Sponsor Product 510(k) No. DANTEC Menuet™ K912701 LifeTech Janus K904386 Wiest Jupiter K860571 Synectics PolyUro K924383 Device Description: The Dantec Duet™ is a computerized ur… | 1991 |
| * | K904386 | Urolab JanusSummary page 1…mon/Usual Name: Urodynamics System Classification Name: Urodynamics Measurement System Predicate Device Sponsor Product 510(k) No. DANTEC Menuet™ K912701 LifeTech Janus K904386 Wiest Jupiter K860571 Synectics PolyUro K924383 Device Description: The Dantec Duet™ is a computerized urodynamics measurement s… | 1990 |
| * | K860571 | F.M. Weist,KG (Urodynamic Systems)Summary page 1…amics System Classification Name: Urodynamics Measurement System Predicate Device Sponsor Product 510(k) No. DANTEC Menuet™ K912701 LifeTech Janus K904386 Wiest Jupiter K860571 Synectics PolyUro K924383 Device Description: The Dantec Duet™ is a computerized urodynamics measurement system. The system cons… | 1986 |
| * | K924383 | Synectics Liberty System, PC Polygraf/Polygram UroSummary page 1…n Name: Urodynamics Measurement System Predicate Device Sponsor Product 510(k) No. DANTEC Menuet™ K912701 LifeTech Janus K904386 Wiest Jupiter K860571 Synectics PolyUro K924383 Device Description: The Dantec Duet™ is a computerized urodynamics measurement system. The system consists of a mobile cart or “… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
How does its category compare?
All FEN devicesFEN Device, Cystometric, Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FEN
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · FEN
Too few FEN 510(k)s in any year since 2007 to give a median.
Recalls per year · FEN
No recall names FEN since 2007.
Adverse event reports per year · FEN
3in 2024
MAUDE reports naming product code FEN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 33 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960503 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960503: Dantec Duet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960503
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026