510(k) · Cleared
ClearedCompass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Innovations, Inc. · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Cleared on Jan 7, 2003 after a 201-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Jan 7, 2003
- Review
- 201 days
- Class
- Class II
- Product code
- KLA
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK022023 Compass Esophageal Pressure Catheter, Model Gie-8500, Compass…Clinical Innovations, Inc. · 2003
- Descendant · cites it directly · 7 of its ownK120088 Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · Recalled
- Descendant · 2 generations on · 4 of its ownK161785 THD AnopressThd Spa · 2017
- Descendant · 2 generations on · 3 of its ownK180135 THD Anopress with THD SensyProbeThd Spa · 2018
- Descendant · 2 generations on · 1 of its ownK143031 mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK032138 Medtronic Single Use Esophageal Manometric Catheter, Medtronic…Medtronic Vascular · 2003
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K120088Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · cites it directly7descendants
- K161785THD AnopressThd Spa · 2017 · 2 generations on4descendants
- K180135THD Anopress with THD SensyProbeThd Spa · 2018 · 2 generations on3descendants
- K143031mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015 · 2 generations on1descendant
- K032138Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal…Medtronic Vascular · 2003 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022023 | Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal… | Clinical Innovations, Inc. | 2003 | — |
| +1 | K120088 | Mcompass Anorectal Manometry System | Medspira, LLC | 2012 | 1 |
| +2 | K161785 | THD Anopress | Thd Spa | 2017 | — |
| +2 | K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018 | — |
| +2 | K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | 2015 | 1 |
| +1 | K032138 | Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use… | Medtronic Vascular | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Konigsberg Esophageal Solid State Catheter Named without a submission number | |
| * | — | Medtronic Zinetics AMs Anorectal Catheter Named without a submission number |
What descends from it? (11)
See all 113 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?
- Of its descendants, K120088 (Medspira, LLC, 2012) has gone furthest, with 7 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.
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?
These catheters are for use on patients requiring gastrointestinal manometry testing. The Esophageal Pressure Catheter Model number GIM-6000E is for use with esophageal motility studies. The Ano-Rectal Pressure Catheter Model number GIM-6000A is for use in ano-rectal pressure studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022023: Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022023
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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