510(k) · Cleared
ClearedFujinon Colonoscopes
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 Jul 26, 2012 as substantially equivalent to K041903 (Fujinon, Inc., 2004) after a 342-day review. Its family tree reaches back 2 generations to 1995. 33 later devices descend from it.
- Decided
- Jul 26, 2012
- Review
- 342 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944759 (1995). 3 ancestors in all. 33 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 1 generation backK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
- This deviceK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
- Descendant · cites it directly · 25 of its ownK132210 Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
- Descendant · 2 generations on · 19 of its ownK160196 Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016
- Descendant · 2 generations on · 18 of its ownK172916 FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and…Fujifilm Corporation · 2018
- Descendant · cites it directly · 6 of its ownK142629 EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK210162 Endoscope Model EI-740D/SFujifilm Corporation · 2021
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014 · cites it directly25descendants
- K160196Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016 · 2 generations on19descendants
- K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM…Fujifilm Corporation · 2018 · 2 generations on18descendants
- K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc. · 2015 · cites it directly6descendants
- K210162Endoscope Model EI-740D/SFujifilm Corporation · 2021 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −1 | K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 | Fujinon, Inc. | 2004 | 1 |
| 0 (this device) | K112391 | Fujinon Colonoscopes | Fujinon, Inc. | 2012 | — |
| +1 | K132210 | Fujifilm 600 Series Endoscopes | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| +2 | K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | Fujifilm Medical Systems U.S.A, Inc. | 2016 | — |
| +2 | K172916 | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and… | Fujifilm Corporation | 2018 | — |
| +1 | K142629 | EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes | Fujifilm Medical System U.S.A., Inc. | 2015 | — |
| +2 | K210162 | Endoscope Model EI-740D/S | Fujifilm Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Summary page 1…Fujinon Colonoscope EC-530HL2 and EC-530LS2 are modified versions of our previously- cleared Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5 as described in K041903. The modified models are intended for observation, diagnosis, and endoscopic treatment of the lower digestive tract, which inc… | 2004 |
What descends from it? (33)
See all 332 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 17 years and passes through 1 company; a new generation was cleared every 9.6 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K132210 (Fujifilm Medical Systems U.S.A, Inc., 2014) has gone furthest, with 25 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. 2012, 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?
This device is intended for the visualization of the lower digestive tract, specifically.
for the observation, diagnosis, and endoscopic treatment of the rectum and large
intestine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112391: Fujinon Colonoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112391
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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