510(k) · Cleared
Clearedmcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medspira, LLC · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Dec 5, 2025 as substantially equivalent to K823701 (Mui Scientific, 1983) and 1 other predicate after a 109-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Dec 5, 2025
- Review
- 109 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K931574 (1993). 9 ancestors in all, the oldest K823701 (1983). No later device cites it as a predicate yet.
- 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 backK143031 mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015 · Recalled
- This deviceK252605 mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC · 2025
View 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 | K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | 2015 | 1 |
| 0 (this device) | 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 |
|---|---|---|
| 1983 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 FFX? 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 FFX device
- #1 K262621 Rapid Barostat Bag (RBB) Pump and Catheter…score 12.4 · 2 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 |
|---|---|---|---|
| * | K823701 | Motility CathetersSummary page 5…876.1725 Product Code(s) FFX | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K823701 SR2B Single-Use PVC Manometric Catheter (Anorectal Balloon FEX Expulsion - Air/Water) K143031 mcompass Biofeedback Anorectal Ca… | 1983 |
| * | K143031 | mcompass Biofeedback Anorectal Manometry SystemSummary page 5…e # Predicate Trade Name (Primary Predicate is listed first) Product Code K823701 SR2B Single-Use PVC Manometric Catheter (Anorectal Balloon FEX Expulsion - Air/Water) K143031 mcompass Biofeedback Anorectal Catheter KLA Device Description Summary 21 CFR 807.92(a)(4) Device Description Summary The mcomp… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K823701.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FFX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FFX
123in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFX
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFX
32in 2025
MAUDE reports naming product code FFX, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 2 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 4 | 120 | 0 | 4 |
| 2013 | 1 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 3 | 145 | 0 | 15 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 4 | 240 | 0 | 27 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 0 | — | 0 | 31 |
| 2023 | 3 | 123 | 0 | 51 |
| 2024 | 1 | — | 0 | 59 |
| 2025 | 1 | — | 0 | 32 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
Use of the mcompass® Anorectal Balloon Expulsion Catheter is indicated when there is a need or suspicion of an anorectal disorder.
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/K252605 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252605: mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252605
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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