510(k) · Cleared
ClearedSolar Compact (G4-1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laborie Medical Technologies, Corp. · FFX System, Gastrointestinal Motility (Electrical)
Cleared on May 6, 2024 as substantially equivalent to K052338 (Medical Measurement Systems B.V., 2005) and 1 other predicate after a 125-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- May 6, 2024
- Review
- 125 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K052338 (2005). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK052338 Solar GIMedical Measurement Systems B.V. · 2005
- This deviceK240007 Solar Compact (G4-1)Laborie Medical Technologies, Corp. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052338 | Solar GI | Medical Measurement Systems B.V. | 2005 | — |
| 0 (this device) | K240007 | Solar Compact (G4-1) | Laborie Medical Technologies, Corp. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K052338 | Solar GISummary page 5…ber 876.1725 Product Code FEX | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K052338 Solar Gl with CIM-AUX FFX K121014 MPP Plus FFX Device Description Summary 21 CFR 807.92(a)(4) The Solar Compact is a medical dev… | 2005 |
| * | K121014 | Solar GISummary page 5…egally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K052338 Solar Gl with CIM-AUX FFX K121014 MPP Plus FFX Device Description Summary 21 CFR 807.92(a)(4) The Solar Compact is a medical device for measuring gastrointestinal… | 2012 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K052338.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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 Compact is intended to record, store, view, and analyze pressure, impedance, and EMG data, gathered from anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, 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 of the gastrointestinal tract. An optional…
Read the full statement (118 words)
The Solar Compact is intended to record, store, view, and analyze pressure, impedance, and EMG data, gathered from anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, 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 of the gastrointestinal tract.
An optional 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.
The Solar Compact is indicated for use in adult to infants with common gastrointestinal conditions, for the monitoring and diagnosis of motility disorders of the Gl tract.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240007: Solar Compact (G4-1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240007
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