510(k) · Cleared
ClearedSolar GI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Measurement Systems B.V. · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Dec 15, 2005 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Dec 15, 2005
- Review
- 111 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK052338 Solar GIMedical Measurement Systems B.V. · 2005
- Descendant · cites it directly · 1 of its ownK091070 Manoscan Motility with Impedance Visualization SystemSierra Scientific Instruments, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK240007 Solar Compact (G4-1)Laborie Medical Technologies, Corp. · 2024
- Descendant · 2 generations on · 0 of its ownK151086 ManoScan SystemGiven Imaging, Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See all- K091070Manoscan Motility with Impedance Visualization SystemSierra Scientific Instruments, Inc. · 2009 · cites it directly1descendant
- K240007Solar Compact (G4-1)Laborie Medical Technologies, Corp. · 2024 · cites it directly0descendants
- K151086ManoScan SystemGiven Imaging, Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052338 | Solar GI | Medical Measurement Systems B.V. | 2005 | — |
| +1 | K091070 | Manoscan Motility with Impedance Visualization System | Sierra Scientific Instruments, Inc. | 2009 | — |
| +1 | K240007 | Solar Compact (G4-1) | Laborie Medical Technologies, Corp. | 2024 | — |
| +2 | K151086 | ManoScan System | Given Imaging, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FFX? 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 FFX device
- #1 K262621 Rapid Barostat Bag (RBB) Pump and Catheter…score 12.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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, K091070 (Sierra Scientific Instruments, Inc., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FFX
123in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFX
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFX
32in 2025
MAUDE reports naming product code FFX, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 2 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 4 | 120 | 0 | 4 |
| 2013 | 1 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 3 | 145 | 0 | 15 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 4 | 240 | 0 | 27 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 0 | — | 0 | 31 |
| 2023 | 3 | 123 | 0 | 51 |
| 2024 | 1 | — | 0 | 59 |
| 2025 | 1 | — | 0 | 32 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The Solar GI system is intended to record, store, view and analyse pressure, EMG, input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052338: Solar GI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052338
Report an extraction error
Are you the manufacturer?
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