510(k) · Cleared
ClearedTHD Anopress with THD SensyProbe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thd Spa · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Cleared on Mar 8, 2018 as substantially equivalent to K161785 (Thd Spa, 2017) and 1 other predicate after a 50-day review. Its family tree reaches back 5 generations to 1993. 3 later devices descend from it.
- Decided
- Mar 8, 2018
- Review
- 50 days
- Class
- Class II
- Product code
- KLA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K931574 (1993). 8 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK931574 Advance Model Uds-AdvLaborie Medical Technologies, Ltd. · 1993
- 4 generations backK073552 Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008
- 3 generations backK082701 Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008
- 2 generations backK120088 Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · Recalled
- 1 generation backK161785 THD AnopressThd Spa · 2017
- This deviceK180135 THD Anopress with THD SensyProbeThd Spa · 2018
- Descendant · cites it directly · 0 of its ownK242666 Fecobionics Anorectal SystemGi Bionics, LLC · 2025
- Descendant · cites it directly · 0 of its ownK242304 REDNeuraxis, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK211623 THD Procto Software SystemThd Spa · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931574 | Advance Model Uds-Adv | Laborie Medical Technologies, Ltd. | 1993 | — |
| −4 | K073552 | Laborie Urodynamic System with Tetra Accessory | Laborie Medical Technologies, Corp. | 2008 | — |
| −3 | K082701 | Uronirs, Model 2000 | Urodynamix Technologies, Ltd. | 2008 | — |
| −2 | K120088 | Mcompass Anorectal Manometry System | Medspira, LLC | 2012 | 1 |
| −1 | K161785 | THD Anopress | Thd Spa | 2017 | — |
| 0 (this device) | K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018 | — |
| +1 | K242666 | Fecobionics Anorectal System | Gi Bionics, LLC | 2025 | — |
| +1 | K242304 | RED | Neuraxis, Inc. | 2024 | — |
| +1 | K211623 | THD Procto Software System | Thd Spa | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 KLA? 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 KLA device
- #1 K242666 Fecobionics Anorectal Systemscore 10.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K161785 | THD AnopressSummary page 4…Applicant Device name 510(k) Number THD SpA THD Anopress K161785 Medspira Mcompass K120088 4. Device Description THD Anopress… | 2017 |
| * | K120088 | Mcompass Anorectal Manometry SystemSummary page 4…THD SpA THD Anopress K161785 Medspira Mcompass K120088 4. Device Description THD Anopress with THD SensyProbe is a handheld, portable anorectal manometry device for its use on pa… | 2012 |
What descends from it? (3)
3 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?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K242666 (Gi Bionics, LLC, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KLA devicesKLA Monitor, Esophageal Motility, Anorectal Motility, And Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KLA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLA
Too few KLA 510(k)s in any year since 2007 to give a median.
Recalls per year · KLA
No recall names KLA since 2007.
Adverse event reports per year · KLA
1in 2024
MAUDE reports naming product code KLA, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The THD Anopress device must be used exclusively to assess the average sphincter tone due to the pressure exerted by the muscles in the anal canal on the specially designed THD Probes. THD Anopress must only be used by appropriately trained medical staff.
Furthermore, the THD SensyProbe enables evaluation of rectal sensitivity and capacity and the ano-rectal inhibitory reflex through connection to a syringe and filling of the balloon on the probe with air.
The THD Anopress with THD SensyProbe is intended to be used in adults only.
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/K180135 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180135: THD Anopress with THD SensyProbe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180135
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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