510(k) · Cleared
ClearedEndogater Avantage CO2 Insufflator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byrne Medical, Inc. · FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Cleared on Jun 20, 2012 as substantially equivalent to K053008 (E-Z-Em, Inc., 2005) after a 225-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Jun 20, 2012
- Review
- 225 days
- Class
- Class II
- Product code
- FCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053008 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK053008 E-Z-EM Endoscopic CO2 RegulatorE-Z-Em, Inc. · 2005
- This deviceK113310 Endogater Avantage CO2 InsufflatorByrne Medical, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053008 | E-Z-EM Endoscopic CO2 Regulator | E-Z-Em, Inc. | 2005 | — |
| 0 (this device) | K113310 | Endogater Avantage CO2 Insufflator | Byrne Medical, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K053008 | E-Z-EM Endoscopic CO2 RegulatorSummary page 1…ass: 11 Regulation No.: 876.1500 Date Prepared: June 8, 2012 Predicate Device: E-Z-EM Endoscopic C02 Regulator 510(k) Number: K053008 Medivators has provided the following information to the U.S. Food and Drug Administration to support the substantial equivalenc… | 2005 |
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K053008.
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. 2012, 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 EndoGator® Advantage CO2 Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
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/K113310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113310: Endogater Avantage CO2 Insufflator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113310
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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