# K121014: Solar GI

- Pathway: 510(k) (Traditional)
- Applicant: Medical Measurement Systems B.V.
- Decided: Aug 1, 2012 after 120 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K240007: Solar Compact (G4-1) (2024), 0 descendants of its own

## Recalls of this device
- May 21, 2026 · Class II · Z-2669-2026: Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter an

## Indications for use
The MVPP Plus is an accessory device to be used with the MMS Solar GI system for intraluminal studies of the gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum) to perfuse demnineralized or distilled water through the lumen of a multi-lumen catheter to measure pressures. The perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump. Designated catheters and accessories are required for measurement in each specific area.

Source page: https://510kreport.com/device/K121014
Methodology: https://510kreport.com/methodology