510(k) · Cleared
ClearedMegachannel Endoscopic Overtube, Model OT22
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minos Medical · ODB Endoscopic Contamination Prevention Sheath
Cleared on Jun 10, 2008 as substantially equivalent to K040836 (United States Endoscopy Group, Inc., 2004) after a 103-day review. Its family tree reaches back 1 generation to 2004. 4 later devices descend from it.
- Decided
- Jun 10, 2008
- Review
- 103 days
- Class
- Class II
- Product code
- ODB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K040836 (2004). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK040836 Disposable OvertubeUnited States Endoscopy Group, Inc. · 2004
- This deviceK080550 Megachannel Endoscopic Overtube, Model OT22Minos Medical · 2008
- Descendant · cites it directly · 3 of its ownK153698 LumenR Tissue Retractor SystemLumenr, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK173400 ORISE Tissue Retractor SystemBoston Scientific · 2018
- Descendant · 3 generations on · 1 of its ownK182540 DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2018
- Descendant · 4 generations on · 0 of its ownK210851 DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC · 2021
Most influential descendants
Showing 4 of 4 · See all- K153698LumenR Tissue Retractor SystemLumenr, LLC · 2016 · cites it directly3descendants
- K173400ORISE Tissue Retractor SystemBoston Scientific · 2018 · 2 generations on2descendants
- K182540DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2018 · 3 generations on1descendant
- K210851DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040836 | Disposable Overtube | United States Endoscopy Group, Inc. | 2004 | — |
| 0 (this device) | K080550 | Megachannel Endoscopic Overtube, Model OT22 | Minos Medical | 2008 | — |
| +1 | K153698 | LumenR Tissue Retractor System | Lumenr, LLC | 2016 | — |
| +2 | K173400 | ORISE Tissue Retractor System | Boston Scientific | 2018 | — |
| +3 | K182540 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2018 | — |
| +4 | K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 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 ODB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040836 | Disposable OvertubeSummary page 1…Classif ication Endoscope and Accessories (21 CER 876.1500) Name: Predicate US Endoscopy Guardus Overtube (K040836) Devices: Spirus Medical Endo-Ease Overtube (K0520840 Device… | 2004 |
| Kept off the family tree | K052840 | FDA’s K052840 is Igi-System Our reading of the summary gave K052840, FDA’s number for Igi-System (Denx Advanced Dental Systems). Its FDA name has none of the distinctive words the summary uses for the device it names, “Spirus Medical Endo-Ease Overtube”. Kept off the family tree. | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153698 | LumenR Tissue Retractor System | 2016 | 3 |
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?
How does its category compare?
All ODB devicesODB Endoscopic Contamination Prevention Sheath: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ODB
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · ODB
Too few ODB 510(k)s in any year since 2007 to give a median.
Recalls per year · ODB
No recall names ODB since 2007.
Adverse event reports per year · ODB
10in 2025
MAUDE reports naming product code ODB, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Megachannel Endoscopic Overtube is indicated for use in conjunction with an endoscope for tissue or foreign body manipulations and/or where multiple removal and reinsertions of the endoscope are required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080550 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080550: Megachannel Endoscopic Overtube, Model OT22.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080550
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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