510(k) · Cleared
ClearedAdvance Model Uds-Adv
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laborie Medical Technologies, Ltd. · EXQ Cystometer, Electrical Recording
Cleared on Aug 5, 1993 after a 128-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.
- Decided
- Aug 5, 1993
- Review
- 128 days
- Class
- Class II
- Product code
- EXQ
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK931574 Advance Model Uds-AdvLaborie Medical Technologies, Ltd. · 1993
- Descendant · cites it directly · 10 of its ownK073552 Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008
- Descendant · 2 generations on · 8 of its ownK082701 Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008
- Descendant · 3 generations on · 7 of its ownK120088 Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · Recalled
- Descendant · 4 generations on · 4 of its ownK161785 THD AnopressThd Spa · 2017
- Descendant · 4 generations on · 3 of its ownK180135 THD Anopress with THD SensyProbeThd Spa · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K073552Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008 · cites it directly10descendants
- K082701Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008 · 2 generations on8descendants
- K120088Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · 3 generations on7descendants
- K161785THD AnopressThd Spa · 2017 · 4 generations on4descendants
- K180135THD Anopress with THD SensyProbeThd Spa · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931574 | Advance Model Uds-Adv | Laborie Medical Technologies, Ltd. | 1993 | — |
| +1 | K073552 | Laborie Urodynamic System with Tetra Accessory | Laborie Medical Technologies, Corp. | 2008 | — |
| +2 | K082701 | Uronirs, Model 2000 | Urodynamix Technologies, Ltd. | 2008 | — |
| +3 | K120088 | Mcompass Anorectal Manometry System | Medspira, LLC | 2012 | 1 |
| +4 | K161785 | THD Anopress | Thd Spa | 2017 | — |
| +4 | K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EXQ? 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 EXQ device
- #1 K253537 Glean Urodynamics System Male Delivery System…score 11.2 · 1 generation · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073552 | Laborie Urodynamic System with Tetra Accessory | 2008 | 10 |
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?
- Of its descendants, K073552 (Laborie Medical Technologies, Corp., 2008) has gone furthest, with 10 descendants of its own.
How does its category compare?
All EXQ devicesEXQ Cystometer, Electrical Recording: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EXQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EXQ
Too few EXQ 510(k)s in any year since 2007 to give a median.
Recalls per year · EXQ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EXQ
1in 2024
MAUDE reports naming product code EXQ, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K931574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931574: Advance Model Uds-Adv.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931574
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026