510(k) · Cleared
ClearedFecobionics Anorectal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gi Bionics, LLC · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Cleared on Feb 12, 2025 as substantially equivalent to K180135 (Thd Spa, 2018) after a 160-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Feb 12, 2025
- Review
- 160 days
- Class
- Class II
- Product code
- KLA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931574 (1993). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK931574 Advance Model Uds-AdvLaborie Medical Technologies, Ltd. · 1993
- 5 generations backK073552 Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008
- 4 generations backK082701 Uronirs, Model 2000Urodynamix Technologies, Ltd. · 2008
- 3 generations backK120088 Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · Recalled
- 2 generations backK161785 THD AnopressThd Spa · 2017
- 1 generation backK180135 THD Anopress with THD SensyProbeThd Spa · 2018
- This deviceK242666 Fecobionics Anorectal SystemGi Bionics, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931574 | Advance Model Uds-Adv | Laborie Medical Technologies, Ltd. | 1993 | — |
| −5 | K073552 | Laborie Urodynamic System with Tetra Accessory | Laborie Medical Technologies, Corp. | 2008 | — |
| −4 | K082701 | Uronirs, Model 2000 | Urodynamix Technologies, Ltd. | 2008 | — |
| −3 | K120088 | Mcompass Anorectal Manometry System | Medspira, LLC | 2012 | 1 |
| −2 | K161785 | THD Anopress | Thd Spa | 2017 | — |
| −1 | K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018 | — |
| 0 (this device) | 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 |
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 K242304 REDscore 10.0 · 6 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K180135 | THD Anopress with THD SensyProbeSummary page 5…Regulation: KLA, 21CFR 876.1725 III. PREDICATE DEVICE Primary Predicate THD AnoPress with THD SensyProbe Anorectal Manometry System (K180135) This predicate has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The Fecobioni… | 2018 |
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 6 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K180135.
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. 2025, 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 Fecobionics Anorectal System is for use on patients requiring anorectal pressure studies and testing of defecatory function. The Fecobionics System must only be used by appropriately trained clinicians. The Fecobionics System enables evaluation of rectal sensitivity, rectal volume and shape, rectoanal inhibitory reflex, anal diameter during defecation, defecatory push pressure, and anorectal angle changes. The Fecobionics device is only intended to be used in adult patients.
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/K242666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242666: Fecobionics Anorectal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242666
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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