510(k) · Cleared
ClearedDiLumen Endolumenal Interventional Platform (DiLumen)
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 Apr 21, 2021 as substantially equivalent to K182540 (Lumendi, LLC, 2018) after a 30-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Apr 21, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K040836 (2004). No later device cites it as a predicate yet.
- Root · 5 generations backK040836 Disposable OvertubeUnited States Endoscopy Group, Inc. · 2004
- 4 generations backK080550 Megachannel Endoscopic Overtube, Model OT22Minos Medical · 2008
- 3 generations backK153698 LumenR Tissue Retractor SystemLumenr, LLC · 2016
- 2 generations backK173400 ORISE Tissue Retractor SystemBoston Scientific · 2018
- 1 generation backK182540 DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2018
- This deviceK210851 DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K040836 | Disposable Overtube | United States Endoscopy Group, Inc. | 2004 | — |
| −4 | K080550 | Megachannel Endoscopic Overtube, Model OT22 | Minos Medical | 2008 | — |
| −3 | K153698 | LumenR Tissue Retractor System | Lumenr, LLC | 2016 | — |
| −2 | K173400 | ORISE Tissue Retractor System | Boston Scientific | 2018 | — |
| −1 | K182540 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2018 | — |
| 0 (this device) | K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | 2021 | — |
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 |
|---|---|---|---|
| * | K182540 | DiLumen Endolumenal Interventional PlatformSummary page 4…roenterology/Urology Regulation / Product Code: 21 C.F.R. § 876.1500; FDF Predicate Device: x Lumendi, LLC’s DiLumen Endolumenal Interventional Platform (K182540) Purpose of the Special 510(k) Notice: The subject device incorporates minor technological modifications to the DiLumen cleared… | 2018 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
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. 2021, 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 DilLumen 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210851: DiLumen Endolumenal Interventional Platform (DiLumen).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210851
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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