510(k) · Cleared
ClearedUronirs, Model 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urodynamix Technologies, Ltd. · FEN Device, Cystometric, Hydraulic
Cleared on Dec 18, 2008 as substantially equivalent to K073552 (Laborie Medical Technologies, Corp., 2008) after a 93-day review. Its family tree reaches back 2 generations to 1993. 8 later devices descend from it.
- Decided
- Dec 18, 2008
- Review
- 93 days
- Class
- Class II
- Product code
- FEN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931574 (1993). 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931574 Advance Model Uds-AdvLaborie Medical Technologies, Ltd. · 1993
- 1 generation backK073552 Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008
- This deviceK082701 Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008
- Descendant · cites it directly · 7 of its ownK120088 Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · Recalled
- Descendant · 2 generations on · 4 of its ownK161785 THD AnopressThd Spa · 2017
- Descendant · 2 generations on · 3 of its ownK180135 THD Anopress with THD SensyProbeThd Spa · 2018
- Descendant · 2 generations on · 1 of its ownK143031 mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015 · Recalled
- Descendant · 3 generations on · 0 of its ownK252605 mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K120088Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · cites it directly7descendants
- K161785THD AnopressThd Spa · 2017 · 2 generations on4descendants
- K180135THD Anopress with THD SensyProbeThd Spa · 2018 · 2 generations on3descendants
- K143031mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015 · 2 generations on1descendant
- K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931574 | Advance Model Uds-Adv | Laborie Medical Technologies, Ltd. | 1993 | — |
| −1 | K073552 | Laborie Urodynamic System with Tetra Accessory | Laborie Medical Technologies, Corp. | 2008 | — |
| 0 (this device) | K082701 | Uronirs, Model 2000 | Urodynamix Technologies, Ltd. | 2008 | — |
| +1 | K120088 | Mcompass Anorectal Manometry System | Medspira, LLC | 2012 | 1 |
| +2 | K161785 | THD Anopress | Thd Spa | 2017 | — |
| +2 | K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018 | — |
| +2 | K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | 2015 | 1 |
| +3 | K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K073552 | Laborie Urodynamic System with Tetra AccessorySummary page 1…2 III. Predicate Device The URONIRS 2000 is substantially equivalent to the following predicate device: · Urodynamic System Tetra Accessory (K073552) from Laborie Medical Technologies Inc. IV. Intended Use of the Device The URONIRS 2000 device is… | 2008 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120088 | Mcompass Anorectal Manometry System | 2012 | 7 |
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K120088 (Medspira, LLC, 2012) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K073552.
How does its category compare?
All FEN devicesFEN Device, Cystometric, Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
The URONIRS 2000 device is indicated for non-invasive testing of bladder activity in an office or hospital setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082701 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082701: Uronirs, Model 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082701
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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