510(k) · Cleared
ClearedMedicCO2LON (MedicCO2LON)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ide Vision, Ltd. · FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Cleared on Oct 30, 2024 as substantially equivalent to K132192 (Bracco Diagnostic, Inc., 2014) after a 217-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Oct 30, 2024
- Review
- 217 days
- Class
- Class II
- Product code
- FCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013219 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK013219 PROTOCO2L Insufflator Model 6400E-Z-Em, Inc. · 2002
- 2 generations backK030854 PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400E-Z-Em, Inc. · 2003
- 1 generation backK132192 Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorBracco Diagnostic, Inc. · 2014
- This deviceK240847 MedicCO2LON (MedicCO2LON)Ide Vision, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013219 | PROTOCO2L Insufflator Model 6400 | E-Z-Em, Inc. | 2002 | — |
| −2 | K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400 | E-Z-Em, Inc. | 2003 | — |
| −1 | K132192 | Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator | Bracco Diagnostic, Inc. | 2014 | — |
| 0 (this device) | K240847 | MedicCO2LON (MedicCO2LON) | Ide Vision, Ltd. | 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 FCX? 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 FCX device
- #1 K262152 VS-370CF, VS-370CTscore 15.3 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K132192 | Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorSummary page 5…FCX Predicate Device Information: Predicate Device: BRACCO PROTOC02L TOUCH Colon Insufflator 510(k) K132192 Registered in the United Kingdom. Registration number 13030037… | 2014 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FCX devicesFCX Insufflator, Automatic Carbon-Dioxide For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FCX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FCX
Too few FCX 510(k)s in any year since 2007 to give a median.
Recalls per year · FCX
1in 2013
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FCX
143in 2025
MAUDE reports naming product code FCX, 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 | 5 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 13 |
| 2013 | 1 | — | 1 (1) | 19 |
| 2014 | 2 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 1 | — | 0 | 54 |
| 2024 | 1 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 143 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MedicCO2LON device is intended to be used for colonic distension with CO2 gas for CT Colonography and conventional Colonoscopy procedures. MedicCO2LON is designed to function with specific colonic insufflation administration sets that allow passage of gas from the device to the colorectal cavity. MedicCO2LON should only be used with administration sets specifically designed for this purpose. The device should only be used by personnel trained in the…
Read the full statement (109 words)
The MedicCO2LON device is intended to be used for colonic distension with CO2 gas for CT Colonography and conventional Colonoscopy procedures.
MedicCO2LON is designed to function with specific colonic insufflation administration sets that allow passage of gas from the device to the colorectal cavity. MedicCO2LON should only be used with administration sets specifically designed for this purpose.
The device should only be used by personnel trained in the practice of undertaking CT Colonography and conventional Colonoscopy examinations and the use of an automatic insuffiation device.
The device should only be used for CT Colonography or conventional Colonoscopy procedures and should not be used for any other patient examination procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240847: MedicCO2LON (MedicCO2LON).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240847
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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