510(k) · Cleared
ClearedLaborie Urodynamic System with Tetra Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laborie Medical Technologies, Corp. · FEN Device, Cystometric, Hydraulic
Cleared on Mar 5, 2008 as substantially equivalent to K931574 (Laborie Medical Technologies, Ltd., 1993) after a 78-day review. Its family tree reaches back 1 generation to 1993. 10 later devices descend from it.
- Decided
- Mar 5, 2008
- Review
- 78 days
- Class
- Class II
- Product code
- FEN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931574 (1993). 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931574 Advance Model Uds-AdvLaborie Medical Technologies, Ltd. · 1993
- This deviceK073552 Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008
- Descendant · cites it directly · 8 of its ownK082701 Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008
- Descendant · 2 generations on · 7 of its ownK120088 Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · Recalled
- Descendant · 3 generations on · 4 of its ownK161785 THD AnopressThd Spa · 2017
- Descendant · 3 generations on · 3 of its ownK180135 THD Anopress with THD SensyProbeThd Spa · 2018
- Descendant · 3 generations on · 1 of its ownK143031 mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K082701Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008 · cites it directly8descendants
- K120088Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · 2 generations on7descendants
- K161785THD AnopressThd Spa · 2017 · 3 generations on4descendants
- K180135THD Anopress with THD SensyProbeThd Spa · 2018 · 3 generations on3descendants
- K143031mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931574 | Advance Model Uds-Adv | Laborie Medical Technologies, Ltd. | 1993 | — |
| 0 (this device) | K073552 | Laborie Urodynamic System with Tetra Accessory | Laborie Medical Technologies, Corp. | 2008 | — |
| +1 | K082701 | Uronirs, Model 2000 | Urodynamix Technologies, Ltd. | 2008 | — |
| +2 | K120088 | Mcompass Anorectal Manometry System | Medspira, LLC | 2012 | 1 |
| +3 | K161785 | THD Anopress | Thd Spa | 2017 | — |
| +3 | K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018 | — |
| +3 | K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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), 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 2.8 · 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 |
|---|---|---|---|
| * | K931574 | Advance Model Uds-AdvSummary page 3…(per 21 CFR 807.92) VIII. Safety & Effectiveness The Laborie Urodynamic with Tetra Accessory is substantially equivalent to the Laborie Urodynamic Analyzer K931574 .There are no substantial differences except for the additional technology of the Tetra component for non invasive diagno… | 1993 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K082701 (Urodynamix Technologies, Ltd., 2008) has gone furthest, with 8 descendants of its own.
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?
Laborie Urodynamic systems are intended for Urodynamic testing. The traditional equipment performs standard test including uroflometry, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra near infrared spectroscopy, uses non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms, that is patients who suffer from urinary incontinence
All Urodynamic equipment including the Laborie Urodynamic system with Tetra Accessory are for use under the direction of a licensed physician or health care professional in an office or hospital setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073552: Laborie Urodynamic System with Tetra Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073552
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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