510(k) · Cleared
ClearedFujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujinon, Inc. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Apr 22, 2009 as substantially equivalent to K041903 (Fujinon, Inc., 2004) and 1 other predicate after a 91-day review. Its family tree reaches back 2 generations to 2000. 45 later devices descend from it.
- Decided
- Apr 22, 2009
- Review
- 91 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K993704 (2000). 5 ancestors in all, the oldest K944759 (1995). 45 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 1 generation backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- This deviceK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- Descendant · cites it directly · 19 of its ownK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015
- Descendant · 2 generations on · 8 of its ownK162749 FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. · 2017
- Descendant · cites it directly · 7 of its ownK162428 DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2016
- Descendant · cites it directly · 7 of its ownK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015 · cites it directly19descendants
- K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. · 2017 · 2 generations on8descendants
- K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2016 · cites it directly7descendants
- K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009 · cites it directly7descendants
- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −1 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| 0 (this device) | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 | Fujinon, Inc. | 2009 | — |
| +1 | K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | Fujifilm Medical Systems U.S.A, Inc. | 2015 | — |
| +2 | K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
| +1 | K162428 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2016 | — |
| +1 | K092156 | Cad 12, Colonoscopy Assist Device | Softscope Medical Technologies, Inc. | 2009 | — |
| +2 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Summary page 2…fication Name: Colonoscope Classification: Class II,21 CFR 876.1500, FDF Predicate Device [21 CFR 807.92(a)(3)] * Fujinon EG-450HL5 (K041903) * Fujinon. EN-450P5/20 (K040048) Description of the Device [21 CFR 807.92(a)(4)] The device is intended for the optical vi… | 2004 |
| * | K040048 | Fujinon Double Balloon Enteroscopy SystemSummary page 2…ification: Class II,21 CFR 876.1500, FDF Predicate Device [21 CFR 807.92(a)(3)] * Fujinon EG-450HL5 (K041903) * Fujinon. EN-450P5/20 (K040048) Description of the Device [21 CFR 807.92(a)(4)] The device is intended for the optical visualization of the gastrointestinal tra… | 2004 |
What descends from it? (45)
See all 457 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | 2015 | 19 |
| K162428 | DiLumen Endolumenal Interventional Platform | 2016 | 7 |
| K092156 | Cad 12, Colonoscopy Assist Device | 2009 | 7 |
| K122565 | Arc Endocuff | 2012 | 4 |
| K183683 | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 | 2019 | 2 |
| K102616 | Naviaid Balloon Guided Colonoscopy (BGC) Device | 2010 | 2 |
| K091773 | Fujinon Sterile Overtubes | 2009 | 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 9 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K143556 (Fujifilm Medical Systems U.S.A, Inc., 2015) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K041903.
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. 2009, 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 device is intended for the optical visualization of the gastrointestinal tract. This includes the rectum,
large and small intestines. It is intended for observation, diagnosis, and endoscopic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090116: Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090116
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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