# K234107: Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)

- Pathway: 510(k) (Traditional)
- Applicant: Laborie Medical Technologies, Corp.
- Decided: Apr 23, 2024 after 119 days
- Product code: KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube)
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K022023 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022023: Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500, Clinical Innovations, Inc. (2003) Summary page 5.

## Indications for use
The Solar anorectal manometry catheter is a non-sterile, single patient use catheter for use on patient requiring anorectal manometry testing.

Source page: https://510kreport.com/device/K234107
Methodology: https://510kreport.com/methodology