510(k) · Cleared
Recalled · Class II · 2017mcompass Biofeedback 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 Jul 7, 2015 as substantially equivalent to K120088 (Medspira, LLC, 2012) after a 259-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 7, 2015
- Review
- 259 days
- Class
- Class II
- Product code
- KLA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K931574 (1993). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK931574 Advance Model Uds-AdvLaborie Medical Technologies, Ltd. · 1993
- 3 generations backK073552 Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008
- 2 generations backK082701 Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008
- 1 generation backK120088 Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · Recalled
- This deviceK143031 mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015
- Descendant · cites it directly · 0 of its ownK252605 mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931574 | Advance Model Uds-Adv | Laborie Medical Technologies, Ltd. | 1993 | — |
| −3 | K073552 | Laborie Urodynamic System with Tetra Accessory | Laborie Medical Technologies, Corp. | 2008 | — |
| −2 | K082701 | Uronirs, Model 2000 | Urodynamix Technologies, Ltd. | 2008 | — |
| −1 | K120088 | Mcompass Anorectal Manometry System | Medspira, LLC | 2012 | 1 |
| 0 (this device) | K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | 2015 | — |
| +1 | K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K120088 | Mcompass Anorectal Manometry SystemSummary page 4…nitoring system (21 CFR 876.1725) Regulatory Class: II Product Code: KLA, HCC Predicate Device: mcompass Anorectal Manometry System (K120088) This device has not been subject to a design-related recall. Device Description: The mcompass Biofeedbac… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | 2025 | 0 |
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 22 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K252605 (Medspira, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K120088.
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. 2015, 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 Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies and biofeedback therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143031: mcompass Biofeedback 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/K143031
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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