510(k) · Cleared
ClearedBracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set
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 Aug 6, 2013 as substantially equivalent to K053008 (E-Z-Em, Inc., 2005) and 1 other predicate after a 312-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Aug 6, 2013
- Review
- 312 days
- Class
- Class II
- Product code
- FCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K853585 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 1 generation backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- This deviceK123047 Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing SetBracco Diagnostic, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −1 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| 0 (this device) | K123047 | Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set | Bracco Diagnostic, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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? (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…Number Manufacturer and Model Bracco Diagnostics, 'K053008 E-Z-EM, Inc. (now Inc. CO 2 BDI) CO 2 Efficient… | 2005 |
| * | K954451 | Evis 140 SystemSummary page 1…pic TNSUFELATOR IN Insuffiator LINE TUBING SET K954451I Olympus America, Inc. EVIS 140 System… | 1996 |
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 27 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 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. 2013, 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 CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET is intended to connect a CO2 source (insuflator), and a sterile water source (water bottle), to an endoscope to supply CO2 during gastrointestinal endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123047: Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123047
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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