510(k) · Cleared
ClearedFUJIFILM Endoscope Models EC-600HL and EC-600LS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Mar 15, 2018 as substantially equivalent to K162622 (Fujifilm Medical Systems U.S.A, Inc., 2016) after a 29-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Mar 15, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K944759 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 5 generations backK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
- 4 generations backK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
- 3 generations backK132210 Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
- 2 generations backK143732 FUJIFILM Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. · 2015
- 1 generation backK162622 Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. · 2016
- This deviceK180405 FUJIFILM Endoscope Models EC-600HL and EC-600LSFujifilm Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −5 | K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 | Fujinon, Inc. | 2004 | 1 |
| −4 | K112391 | Fujinon Colonoscopes | Fujinon, Inc. | 2012 | — |
| −3 | K132210 | Fujifilm 600 Series Endoscopes | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| −2 | K143732 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | Fujifilm Medical Systems U.S.A, Inc. | 2015 | — |
| −1 | K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LS | Fujifilm Medical Systems U.S.A, Inc. | 2016 | — |
| 0 (this device) | K180405 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | Fujifilm Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LSSummary page 4…C.F.R. § 876.1500 Product Code: FDF Predicate Device: Fujifilm Endoscope Models EC-600HL and EC-600LS, Fujifilm Medical Systems U.S.A, K162622 Intended Use / Indications for Use: These devices are intended for the visualization of the lower digestive trac… | 2016 |
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 23 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 8 ancestors have a recall of any class.
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 devices are 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/K180405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180405: FUJIFILM Endoscope Models EC-600HL and EC-600LS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180405
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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