510(k) · Cleared
ClearedSolar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laborie Medical Technologies, Corp. · KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Cleared on Apr 23, 2024 as substantially equivalent to K022023 (Clinical Innovations, Inc., 2003) after a 119-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Apr 23, 2024
- Review
- 119 days
- Class
- Class II
- Product code
- KLA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022023 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK022023 Compass Esophageal Pressure Catheter, Model Gie-8500, Compass…Clinical Innovations, Inc. · 2003
- This deviceK234107 Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022023 | Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal… | Clinical Innovations, Inc. | 2003 | — |
| 0 (this device) | K234107 | Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | Laborie Medical Technologies, Corp. | 2024 | — |
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
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 |
|---|---|---|---|
| * | K022023 | Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure…Summary page 5…: 21 CFR 876.1725 Product Code: KLA Device Classification: Class II Legally Marketed Predicate Device Predicate 510(k) Number: K022023 Predicate Trade Name: Latitude Anorectal Pressure Catheter (Model: GIM-6000A) Product Code:… | 2003 |
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?
- Its one ancestor has no recall.
- 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. 2024, 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 Solar anorectal manometry catheter is a non-sterile, single patient use catheter for use on patient requiring anorectal manometry testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234107 · printed Nov 5, 2026
Cite this page
510(k) Report. “K234107: Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K234107
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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