510(k) · Cleared
Recalled · Class II · 2017Mcompass Anorectal Manometry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medspira, LLC · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Cleared on Mar 29, 2012 as substantially equivalent to K022023 (Clinical Innovations, Inc., 2003) and 2 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1993. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 29, 2012
- Review
- 78 days
- Class
- Class II
- Product code
- KLA
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K931574 (1993). 6 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK931574 Advance Model Uds-AdvLaborie Medical Technologies, Ltd. · 1993
- 2 generations backK073552 Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008
- 1 generation backK082701 Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008
- This deviceK120088 Mcompass Anorectal Manometry SystemMedspira, LLC · 2012
- Descendant · cites it directly · 4 of its ownK161785 THD AnopressThd Spa · 2017
- Descendant · cites it directly · 3 of its ownK180135 THD Anopress with THD SensyProbeThd Spa · 2018
- Descendant · cites it directly · 1 of its ownK143031 mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK252605 mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK242666 Fecobionics Anorectal SystemGi Bionics, LLC · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161785THD AnopressThd Spa · 2017 · cites it directly4descendants
- K180135THD Anopress with THD SensyProbeThd Spa · 2018 · cites it directly3descendants
- K143031mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015 · cites it directly1descendant
- K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC · 2025 · 2 generations on0descendants
- K242666Fecobionics Anorectal SystemGi Bionics, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931574 | Advance Model Uds-Adv | Laborie Medical Technologies, Ltd. | 1993 | — |
| −2 | K073552 | Laborie Urodynamic System with Tetra Accessory | Laborie Medical Technologies, Corp. | 2008 | — |
| −1 | K082701 | Uronirs, Model 2000 | Urodynamix Technologies, Ltd. | 2008 | — |
| 0 (this device) | K120088 | Mcompass Anorectal Manometry System | Medspira, LLC | 2012 | — |
| +1 | K161785 | THD Anopress | Thd Spa | 2017 | — |
| +1 | K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018 | — |
| +1 | K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | 2015 | 1 |
| +2 | K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, LLC | 2025 | — |
| +2 | K242666 | Fecobionics Anorectal System | Gi Bionics, LLC | 2025 | — |
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 |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K022023 | Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure…Summary page 1…tinal motility monitoring system (21 CFR 876.1725) Product Code: KLA Predicate Device(s): * Latitude Anm-Rectal Pressure Catheter (K022023) * Latitude Directional Anorectal Manometry Catheter (5 10(k) number n… | 2003 |
| * | K082701 | Uronirs, Model 2000Summary page 1…* Latitude Directional Anorectal Manometry Catheter (5 10(k) number not available) * uroNIRS 2000 (K(082701) * Manoscan 360AR (K03 1169) Device Description: The meompass device is a manometry system for the… | 2008 |
| * | K031169 | Motility Visualization SystemSummary page 1…atheter (5 10(k) number not available) * uroNIRS 2000 (K(082701) * Manoscan 360AR (K03 1169) Device Description: The meompass device is a manometry system for the measurement of anorectal pressur… | 2003 |
| * | — | Latitude Directional Anorectal Manometry Catheter Named without a submission number |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2017 | Class II | Z-3072-2017 | Employee error | Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K161785 (Thd Spa, 2017) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K022023.
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. 2012, 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 mcompass Anorectal Manomnetry System is for use on patients requiring anorectal pressure studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120088: Mcompass Anorectal Manometry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120088
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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