510(k) · Cleared
ClearedDiLumen Endolumenal Interventional Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumendi, LLC · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Oct 30, 2018 as substantially equivalent to K173400 (Boston Scientific, 2018) after a 46-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.
- Decided
- Oct 30, 2018
- Review
- 46 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K040836 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK040836 Disposable OvertubeUnited States Endoscopy Group, Inc. · 2004
- 3 generations backK080550 Megachannel Endoscopic Overtube, Model OT22Minos Medical · 2008
- 2 generations backK153698 LumenR Tissue Retractor SystemLumenr, LLC · 2016
- 1 generation backK173400 ORISE Tissue Retractor SystemBoston Scientific · 2018
- This deviceK182540 DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2018
- Descendant · cites it directly · 0 of its ownK210851 DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K210851DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040836 | Disposable Overtube | United States Endoscopy Group, Inc. | 2004 | — |
| −3 | K080550 | Megachannel Endoscopic Overtube, Model OT22 | Minos Medical | 2008 | — |
| −2 | K153698 | LumenR Tissue Retractor System | Lumenr, LLC | 2016 | — |
| −1 | K173400 | ORISE Tissue Retractor System | Boston Scientific | 2018 | — |
| 0 (this device) | K182540 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2018 | — |
| +1 | K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 FDF? 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 FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K173400 | ORISE Tissue Retractor SystemSummary page 4…Urology Classification Regulation / Product Code: 21 C.F.R. § 876.1500 Endoscope and Accessories; FDF Predicate/Reference Devices: • ORISE Tissue Retractor System (K173400) (predicate device) • DiLumen Endolumenal Interventional Platform (K162428) (reference device) Intended Use / Indications f… | 2018 |
| † | K162428 | DiLumen Endolumenal Interventional Platform | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | 2021 | 0 |
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 14 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K210851 (Lumendi, LLC, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 4 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
What is it indicated for?
The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 – 14.3 mm. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, and endoscopic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182540 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182540: DiLumen Endolumenal Interventional Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182540
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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