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 Dec 6, 2016 as substantially equivalent to K090116 (Fujinon, Inc., 2009) after a 98-day review. Its family tree reaches back 3 generations to 2000. 7 later devices descend from it.
- Decided
- Dec 6, 2016
- Review
- 98 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993704 (2000). 6 ancestors in all, the oldest K944759 (1995). 7 later devices descend from it, 2 citing it directly.
- 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 deviceK162428 DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2016
- Descendant · cites it directly · 4 of its ownK173317 DiLumen C2; DiLumen Tool MountLumendi, LLC · 2018
- Descendant · 2 generations on · 3 of its ownK211819 DiLumen C2 and Tool MountLumendi, LLC · 2021
- Descendant · 3 generations on · 2 of its ownK221452 DiLumen C1, EZ1 and Tool MountLumendi, LLC · 2023
- Descendant · 4 generations on · 1 of its ownK231323 Ancora-SBAspero Medical, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK213773 Insufflation Retention DeviceBpendo, LLC · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K173317DiLumen C2; DiLumen Tool MountLumendi, LLC · 2018 · cites it directly4descendants
- K211819DiLumen C2 and Tool MountLumendi, LLC · 2021 · 2 generations on3descendants
- K221452DiLumen C1, EZ1 and Tool MountLumendi, LLC · 2023 · 3 generations on2descendants
- K231323Ancora-SBAspero Medical, Inc. · 2023 · 4 generations on1descendant
- K213773Insufflation Retention DeviceBpendo, LLC · 2022 · cites it directly1descendant
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) | K162428 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2016 | — |
| +1 | K173317 | DiLumen C2; DiLumen Tool Mount | Lumendi, LLC | 2018 | — |
| +2 | K211819 | DiLumen C2 and Tool Mount | Lumendi, LLC | 2021 | — |
| +3 | K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | 2023 | — |
| +4 | K231323 | Ancora-SB | Aspero Medical, Inc. | 2023 | — |
| +1 | K213773 | Insufflation Retention Device | Bpendo, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Summary page 4…ssification: 21 C.F.R. § 876.1500 (Endoscope and accessories) Product Code: FDF Predicate/Reference Devices: • Fujinon EC-450B15 Double Balloon Enteroscopy System (K090116) • Smart Medical Systems NaviAID™ BGE (K060923) (reference device) • Smart Medical Systems NaviAID™ BGC (K102616) (refe… | 2009 |
| † | K060923 | Naviaid Bge Device, Model 21-001 | 2006 |
| † | K102616 | Naviaid Balloon Guided Colonoscopy (BGC) Device | 2010 |
What descends from it? (7)
2 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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K173317 (Lumendi, LLC, 2018) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K090116.
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. 2016, 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 and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162428: DiLumen Endolumenal Interventional Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162428
Report an extraction error
Are you the manufacturer?
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