510(k) · Cleared
ClearedOlympus-Keymed Endoscopic CO2 Regulator, Model Ecr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keymed, Inc. · FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Cleared on May 12, 1988 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- May 12, 1988
- Review
- 64 days
- Class
- Class II
- Product code
- FCX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK881004 Olympus-Keymed Endoscopic CO2 Regulator, Model EcrKeymed, Inc. · 1988
- Descendant · cites it directly · 2 of its ownK063786 Endoscopic Insufflation Unit, Model Xecr-2Olympus Medical Systems Corporation · 2007
- Descendant · 2 generations on · 1 of its ownK133976 Fujifilm Endoscopic CO2 RegulatorFujifilm Medical System U.S.A., Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK180711 FUJIFILM Endoscopic CO2 Regulator GW-100Fujifilm Corporation · 2018
Most influential descendants
Showing 3 of 3 · See all- K063786Endoscopic Insufflation Unit, Model Xecr-2Olympus Medical Systems Corporation · 2007 · cites it directly2descendants
- K133976Fujifilm Endoscopic CO2 RegulatorFujifilm Medical System U.S.A., Inc. · 2014 · 2 generations on1descendant
- K180711FUJIFILM Endoscopic CO2 Regulator GW-100Fujifilm Corporation · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881004 | Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr | Keymed, Inc. | 1988 | — |
| +1 | K063786 | Endoscopic Insufflation Unit, Model Xecr-2 | Olympus Medical Systems Corporation | 2007 | — |
| +2 | K133976 | Fujifilm Endoscopic CO2 Regulator | Fujifilm Medical System U.S.A., Inc. | 2014 | — |
| +3 | K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100 | Fujifilm Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063786 | Endoscopic Insufflation Unit, Model Xecr-2 | 2007 | 2 |
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?
- Of its descendants, K063786 (Olympus Medical Systems Corporation, 2007) has gone furthest, with 2 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K881004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881004: Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881004
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026