510(k) · Cleared
ClearedE-Z-EM Endoscopic CO2 Regulator
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 Dec 27, 2005 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Dec 27, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- FCX
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 6 citing it directly.
- This deviceK053008 E-Z-EM Endoscopic CO2 RegulatorE-Z-Em, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK111648 Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc. · 2011 · Recalled
- Descendant · cites it directly · 2 of its ownK063786 Endoscopic Insufflation Unit, Model Xecr-2Olympus Medical Systems Corporation · 2007
- Descendant · 2 generations on · 1 of its ownK133976 Fujifilm Endoscopic CO2 RegulatorFujifilm Medical System U.S.A., Inc. · 2014
- Descendant · cites it directly · 0 of its ownK202922 END 200 Endoscopic TubesetPalliare, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK201096 CO2mbiLEDKarl Storz Endoscopy America, Inc. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K111648Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc. · 2011 · cites it directly3descendants
- K063786Endoscopic Insufflation Unit, Model Xecr-2Olympus Medical Systems Corporation · 2007 · cites it directly2descendants
- K133976Fujifilm Endoscopic CO2 RegulatorFujifilm Medical System U.S.A., Inc. · 2014 · 2 generations on1descendant
- K202922END 200 Endoscopic TubesetPalliare, Ltd. · 2021 · cites it directly0descendants
- K201096CO2mbiLEDKarl Storz Endoscopy America, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053008 | E-Z-EM Endoscopic CO2 Regulator | E-Z-Em, Inc. | 2005 | — |
| +1 | K111648 | Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator | Bracco Diagnostic, Inc. | 2011 | 1 |
| +1 | K063786 | Endoscopic Insufflation Unit, Model Xecr-2 | Olympus Medical Systems Corporation | 2007 | — |
| +2 | K133976 | Fujifilm Endoscopic CO2 Regulator | Fujifilm Medical System U.S.A., Inc. | 2014 | — |
| +1 | K202922 | END 200 Endoscopic Tubeset | Palliare, Ltd. | 2021 | — |
| +2 | K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111648 | Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator | 2011 | 3 |
| K063786 | Endoscopic Insufflation Unit, Model Xecr-2 | 2007 | 2 |
| K202922 | END 200 Endoscopic Tubeset | 2021 | 0 |
| K123047 | Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set | 2013 | 0 |
| K113310 | Endogater Avantage CO2 Insufflator | 2012 | 0 |
| K090879 | Insuflow CO2IONSHIELD | 2009 | 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?
- Of its descendants, K111648 (Bracco Diagnostic, Inc., 2011) has gone furthest, with 3 descendants of its own.
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 ENDOSCOPIC C02 REGULATOR is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
The ENDOSCOPIC C02 REGULATOR allows the physician to modulate and control the C02 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the Light Source of the Endoscopic equipment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K053008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053008: E-Z-EM Endoscopic CO2 Regulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053008
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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