510(k) · Cleared
ClearedBracco Diagnostics Inc. Protoco, L Touch Colon Insufflator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bracco Diagnostic, Inc. · FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Cleared on Feb 14, 2014 as substantially equivalent to K030854 (E-Z-Em, Inc., 2003) and 1 other predicate after a 214-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Feb 14, 2014
- Review
- 214 days
- Class
- Class II
- Product code
- FCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K013219 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK013219 PROTOCO2L Insufflator Model 6400E-Z-Em, Inc. · 2002
- 1 generation backK030854 PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400E-Z-Em, Inc. · 2003
- This deviceK132192 Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorBracco Diagnostic, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK240847 MedicCO2LON (MedicCO2LON)Ide Vision, Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240847MedicCO2LON (MedicCO2LON)Ide Vision, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013219 | PROTOCO2L Insufflator Model 6400 | E-Z-Em, Inc. | 2002 | — |
| −1 | K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400 | E-Z-Em, Inc. | 2003 | — |
| 0 (this device) | K132192 | Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator | Bracco Diagnostic, Inc. | 2014 | — |
| +1 | K240847 | MedicCO2LON (MedicCO2LON) | Ide Vision, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400Summary page 1…redicate Predicate Equivalent Devices: 510(k) Number Manufacturer / Model Bracco Diagnostics Inc. K030854 E-Z-EM, Inc. (now BOI)/ PROTOC0 2 L Touch PROTOCO 2 L Colon… | 2003 |
| * | K013219 | PROTOCO2L Insufflator Model 6400Summary page 1…Performance Improvements K013219 E-Z-EM, Inc. (now BDI)/ PROTOCO 2 L Colon… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240847 | MedicCO2LON (MedicCO2LON) | 2024 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 10.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240847 (Ide Vision, Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K030854.
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. 2014, 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 PROTOCO₂ L Touch Colon Insufflator administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132192: Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132192
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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