510(k) · Cleared
ClearedST-E1 Overtube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Jan 23, 1991 after a 155-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.
- Decided
- Jan 23, 1991
- Review
- 155 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 2 citing it directly.
- This deviceK903842 ST-E1 OvertubeOlympus Corp. · 1991
- Descendant · cites it directly · 17 of its ownK023902 Shape-Lockable Endoscopic OvertubeUsgi Medical, Inc. · 2003
- Descendant · 2 generations on · 16 of its ownK033954 Shape Locking Endoscopic OvertubeUsgi Medical, Inc. · 2004
- Descendant · 3 generations on · 13 of its ownK052930 Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006
- Descendant · 3 generations on · 12 of its ownK070622 Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007
- Descendant · 4 generations on · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K023902Shape-Lockable Endoscopic OvertubeUsgi Medical, Inc. · 2003 · cites it directly17descendants
- K033954Shape Locking Endoscopic OvertubeUsgi Medical, Inc. · 2004 · 2 generations on16descendants
- K052930Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006 · 3 generations on13descendants
- K070622Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007 · 3 generations on12descendants
- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903842 | ST-E1 Overtube | Olympus Corp. | 1991 | — |
| +1 | K023902 | Shape-Lockable Endoscopic Overtube | Usgi Medical, Inc. | 2003 | — |
| +2 | K033954 | Shape Locking Endoscopic Overtube | Usgi Medical, Inc. | 2004 | — |
| +3 | K052930 | Navigator Endoscopy System | Neoguide Systems, Inc. | 2006 | — |
| +3 | K070622 | Neoguide Endoscopy System | Neoguide Systems, Inc. | 2007 | — |
| +4 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2026 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K023902 (Usgi Medical, Inc., 2003) has gone furthest, with 17 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K903842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K903842: ST-E1 Overtube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903842
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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