510(k) · Cleared
ClearedFUJIFILM Endoscopic CO2 Regulator GW-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Cleared on May 25, 2018 as substantially equivalent to K133976 (Fujifilm Medical System U.S.A., Inc., 2014) after a 67-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- May 25, 2018
- Review
- 67 days
- Class
- Class II
- Product code
- FCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K881004 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK881004 Olympus-Keymed Endoscopic CO2 Regulator, Model EcrKeymed, Inc. · 1988
- 2 generations backK063786 Endoscopic Insufflation Unit, Model Xecr-2Olympus Medical Systems Corporation · 2007
- 1 generation backK133976 Fujifilm Endoscopic CO2 RegulatorFujifilm Medical System U.S.A., Inc. · 2014
- This deviceK180711 FUJIFILM Endoscopic CO2 Regulator GW-100Fujifilm Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881004 | Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr | Keymed, Inc. | 1988 | — |
| −2 | K063786 | Endoscopic Insufflation Unit, Model Xecr-2 | Olympus Medical Systems Corporation | 2007 | — |
| −1 | K133976 | Fujifilm Endoscopic CO2 Regulator | Fujifilm Medical System U.S.A., Inc. | 2014 | — |
| 0 (this device) | K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100 | Fujifilm Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K133976 | Fujifilm Endoscopic CO2 RegulatorSummary page 4…cessories, 21 C.F.R. § 876.1500 Product Code: FCX Predicate Device: Fujifilm Endoscopic CO2 Regulator GW-100, Fujifilm Medical Systems U.S.A, K133976 Reference Device: FUJIFILM Water Tank WT-603, FUJIFILM Corporation, K172916 Intended Use / Indications for Use: T… | 2014 |
| † | K172916 | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM… | 2018 |
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 30 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
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. 2018, 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?
This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm's endoscopy system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180711 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180711: FUJIFILM Endoscopic CO2 Regulator GW-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180711
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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