510(k) · Cleared
Recalled · Class II · 2015Series 400 Gastroenterology System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marks & Murase · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Apr 27, 1995 after a 219-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 125 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 27, 1995
- Review
- 219 days
- Class
- Class II
- Product code
- FET
- Recalls
- 2
- Predicates
- 0
125 later devices descend from it, 5 citing it directly.
- This deviceK944620 Series 400 Gastroenterology SystemMarks & Murase · 1995
- Descendant · cites it directly · 75 of its ownK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 45 of its ownK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- Descendant · cites it directly · 39 of its ownK042043 Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5Fujinon, Inc. · 2004
- Descendant · cites it directly · 37 of its ownK102466 Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
- Descendant · 2 generations on · 33 of its ownK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 125 · See all- K041903Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · cites it directly75descendants
- K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc. · 2009 · 2 generations on45descendants
- K042043Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5Fujinon, Inc. · 2004 · cites it directly39descendants
- K102466Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011 · cites it directly37descendants
- K112391Fujinon ColonoscopesFujinon, Inc. · 2012 · 2 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944620 | Series 400 Gastroenterology System | Marks & Murase | 1995 | — |
| +1 | K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 | Fujinon, Inc. | 2004 | 1 |
| +2 | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 | Fujinon, Inc. | 2009 | — |
| +1 | K042043 | Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5 | Fujinon, Inc. | 2004 | — |
| +1 | K102466 | Fujinon Epx-4440HD Digital Video Processor | Fujinon, Inc. | 2011 | — |
| +2 | K112391 | Fujinon Colonoscopes | Fujinon, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 8 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 14 | 0 |
| 2020 | 8 | 0 |
| 2021 | 7 | 0 |
| 2022 | 3 | 0 |
| 2023 | 13 | 0 |
| 2024 | 7 | 0 |
| 2025 | 13 | 0 |
| 2026 | 13 | 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 FET? 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (125)
See all 1255 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 | 2004 | 75 |
| K042043 | Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5 | 2004 | 39 |
| K102466 | Fujinon Epx-4440HD Digital Video Processor | 2011 | 37 |
| K132210 | Fujifilm 600 Series Endoscopes | 2014 | 25 |
| K042076 | Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5 | 2004 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2015 | Class II | Z-2778-2015 | Device Design | The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures. |
| Mar 27, 2006 | Not classified | Z-0708-06 | Other | Colonoscope insertion tube is not bending properly and is stiff. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041903 (Fujinon, Inc., 2004) has gone furthest, with 75 descendants of its own.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
https://510kreport.com/device/K944620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944620: Series 400 Gastroenterology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944620
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026