510(k) · Cleared
ClearedInsuflow CO2IONSHIELD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lexion Medical, LLC · FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Cleared on Jul 23, 2009 as substantially equivalent to K063546 (Lexion Medical, LLC, 2007) and 2 other predicates after a 114-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Jul 23, 2009
- Review
- 114 days
- Class
- Class II
- Product code
- FCX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K920986 (1992). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK920986 Snowden-Pencer High Flow Insufflator, SP/88-9700Snowden-Pencer · 1992
- 2 generations backK970866 Filter Heater/Hydrator Insufflation Gas ConditionerGeorgia Biomedical, Inc. · 1998
- 1 generation backK063546 Insuflow Device, Model 6198Lexion Medical, LLC · 2007
- This deviceK090879 Insuflow CO2IONSHIELDLexion Medical, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700 | Snowden-Pencer | 1992 | — |
| −2 | K970866 | Filter Heater/Hydrator Insufflation Gas Conditioner | Georgia Biomedical, Inc. | 1998 | — |
| −1 | K063546 | Insuflow Device, Model 6198 | Lexion Medical, LLC | 2007 | — |
| 0 (this device) | K090879 | Insuflow CO2IONSHIELD | Lexion Medical, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K063546 | Insuflow Device, Model 6198Summary page 1…Equivalent devices LEXION Medical believes that Insuflows CO 2 lonShieldTM is substantially equ.ivalent to the following devices: Insuflowe, K063 546 PROTOC0 2 L Colon Insufflator, K030854 Endoscopic CO 2 Regulator, K053 008 Insuflow®&CO 2 lonS… | 2007 |
| * | K030854 | PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400Summary page 1…t Insuflows CO 2 lonShieldTM is substantially equ.ivalent to the following devices: Insuflowe, K063 546 PROTOC0 2 L Colon Insufflator, K030854 Endoscopic CO 2 Regulator, K053 008 Insuflow®&CO 2 lonShieldTM is the same gas conditioner accessory device… | 2003 |
| * | K053008 | E-Z-EM Endoscopic CO2 RegulatorSummary page 1…equ.ivalent to the following devices: Insuflowe, K063 546 PROTOC0 2 L Colon Insufflator, K030854 Endoscopic CO 2 Regulator, K053 008 Insuflow®&CO 2 lonShieldTM is the same gas conditioner accessory device as the Insuflowe cleared under 5 10(k) K063… | 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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 9 ancestors has a recall.
- 4 other devices also cite its predicate K063546.
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. 2009, 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?
Insuflow®CO 2 lonShieldTM is a gas conditioner accessory device for use during colonoscopy procedures, including CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy procedures, and intraoperative endoscopy procedures, intended to heat, humidify and filter a CO 2 gas stream for administration as a distention media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090879: Insuflow CO2IONSHIELD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090879
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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