510(k) · Cleared
ClearedFujinon Sterile Overtubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujinon, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Aug 7, 2009 as substantially equivalent to K040048 (Fujinon, Inc., 2004) and 1 other predicate after a 52-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Aug 7, 2009
- Review
- 52 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K993704 (2000). 6 ancestors in all, the oldest K944759 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 2 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 1 generation backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- This deviceK091773 Fujinon Sterile OvertubesFujinon, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −2 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −1 | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 | Fujinon, Inc. | 2009 | — |
| 0 (this device) | K091773 | Fujinon Sterile Overtubes | Fujinon, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2004 | 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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 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 |
|---|---|---|---|
| * | K040048 | Fujinon Double Balloon Enteroscopy SystemSummary page 1…ccessories Classification: Class II,21 CFR 876.1500, FDS and KOG Predicate Device [21 CFR 807.92(a)(3)] Fujinon Overtubes included with Double Balloon Enteroscopy - K040048 Fujinon Overtubes included with EC-450B15 - K090116… | 2004 |
| * | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Summary page 1…S and KOG Predicate Device [21 CFR 807.92(a)(3)] Fujinon Overtubes included with Double Balloon Enteroscopy - K040048 Fujinon Overtubes included with EC-450B15 - K090116 Page 112… | 2009 |
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 9 years and passes through 1 company; a new generation was cleared every 4.3 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 9 other devices also cite its predicate K040048.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
The sterile overtubes are intended to be used as accessories with the Fujinon Double Balloon Enteroscopy system, which is used for the optical visualization of the gastrointestinal tract
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091773 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091773: Fujinon Sterile Overtubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091773
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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