510(k) · Cleared
ClearedPROTOCO2L Colon Insufflator with Performance Improvements, Model 6400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E-Z-Em, Inc. · FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Cleared on Apr 16, 2003 as substantially equivalent to K013219 (E-Z-Em, Inc., 2002) after a 29-day review. Its family tree reaches back 1 generation to 2002. 10 later devices descend from it.
- Decided
- Apr 16, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- FCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013219 (2002). 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK013219 PROTOCO2L Insufflator Model 6400E-Z-Em, Inc. · 2002
- This deviceK030854 PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400E-Z-Em, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 2 generations on · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 2 generations on · 2 of its ownK141286 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK161355 invendoscopy E200 SystemInvendo Medical GmbH · 2016
- Descendant · cites it directly · 1 of its ownK132192 Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorBracco Diagnostic, Inc. · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · cites it directly6descendants
- K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on5descendants
- K141286Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014 · 2 generations on2descendants
- K161355invendoscopy E200 SystemInvendo Medical GmbH · 2016 · 2 generations on1descendant
- K132192Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorBracco Diagnostic, Inc. · 2014 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013219 | PROTOCO2L Insufflator Model 6400 | E-Z-Em, Inc. | 2002 | — |
| 0 (this device) | K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400 | E-Z-Em, Inc. | 2003 | — |
| +1 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +2 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +2 | K141286 | Aer-O-Scope Colonoscope System | Gi View, Ltd. | 2014 | — |
| +2 | K161355 | invendoscopy E200 System | Invendo Medical GmbH | 2016 | — |
| +1 | K132192 | Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator | Bracco Diagnostic, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K013219 | PROTOCO2L Insufflator Model 6400 | 2002 |
What descends from it? (10)
3 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?
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.
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 E-Z-EM PROTOCO2L COLON Insufflator administers and regulates carbon dioxide (C02) as a distention media to the colon during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030854: PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030854
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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