510(k) · Cleared
Recalled · Class II · 2021Bracco Diagnostics, Inc. CO2MPACT Endodcopic 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 Nov 3, 2011 as substantially equivalent to K053008 (E-Z-Em, Inc., 2005) and 1 other predicate after a 143-day review. Its family tree reaches back 4 generations to 1993. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 3, 2011
- Review
- 143 days
- Class
- Class II
- Product code
- FCX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K923982 (1993). 9 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK923982 Olympus Oes Laparoscopy SystemOlympus Corp. · 1993 · Recalled
- 3 generations backK955403 Oes Laparo-Thoraco Videoscope Type VOlympus America, Inc. · 1996
- 2 generations backK053382 Laparo-Thoraco Videoscope XLTF-VawOlympus Medical Systems Corporation · 2006
- 1 generation backK081173 Endoscopic CO2 Regulation Unit UcrOlympus Medical Systems Corporation · 2008
- This deviceK111648 Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK201096 CO2mbiLEDKarl Storz Endoscopy America, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK190985 BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK162332 Nexcore GI InsufflatorNexcore Technology, LLC · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923982 | Olympus Oes Laparoscopy System | Olympus Corp. | 1993 | 1 |
| −3 | K955403 | Oes Laparo-Thoraco Videoscope Type V | Olympus America, Inc. | 1996 | — |
| −2 | K053382 | Laparo-Thoraco Videoscope XLTF-Vaw | Olympus Medical Systems Corporation | 2006 | — |
| −1 | K081173 | Endoscopic CO2 Regulation Unit Ucr | Olympus Medical Systems Corporation | 2008 | — |
| 0 (this device) | K111648 | Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator | Bracco Diagnostic, Inc. | 2011 | — |
| +1 | K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | 2020 | — |
| +1 | K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. | 2019 | — |
| +1 | K162332 | Nexcore GI Insufflator | Nexcore Technology, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K053008 | E-Z-EM Endoscopic CO2 RegulatorSummary page 1…510(k) Manufacturer/Model Number Bracco Diagnostics, Inc. K053008 E-Z-EM, Inc. (now BDJ) CO 2 MPACT ENDOSCOPIC / CO 2 Effxeient… | 2005 |
| * | K081173 | Endoscopic CO2 Regulation Unit UcrSummary page 1…/ CO 2 Effxeient II4SUFFLATORTM Endoscopic Insufflator K081 173 Olympus Medical Systems, Corp. / UCR… | 2008 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2021 | Class II | Z-1148-2021 | Nonconforming Material/Component | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K201096 (Karl Storz Endoscopy America, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 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. 2011, 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 Bracco Diagnostics, Inc. (BDI) CO2 MPACT ENDOSCOPIC INSUFFLATOR is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
The BDI CO2 MPACT ENDOSCOPIC INSUFFLATOR allows the physician to modulate and control the CO2 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 summary.
https://510kreport.com/device/K111648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111648: Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111648
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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