510(k) · Cleared
ClearedFUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
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 May 23, 2025 as substantially equivalent to K172916 (Fujifilm Corporation, 2018) and 3 other predicates after a 220-day review. Its family tree reaches back 11 generations to 1993. 3 of the 43 devices in its family, counting itself, have a Class I recall.
- Decided
- May 23, 2025
- Review
- 220 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K931154 (1993). 42 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 3 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations between
- 3 generations backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 2 generations backK131780 Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · Recalled
- 1 generation backK222584 Evis X1 Video System Center Olympus CV-1500, Colonovideoscope…Olympus Medical Systems Corporation · 2023 · Recalled
- This deviceK243261 FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model…Fujifilm Corporation · 2025
Show all 11 generations
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 10 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 9 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 8 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 7 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 6 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 5 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 4 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 3 generations backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 2 generations backK131780 Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · Recalled
- 1 generation backK222584 Evis X1 Video System Center Olympus CV-1500, Colonovideoscope…Olympus Medical Systems Corporation · 2023 · Recalled
- This deviceK243261 FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model…Fujifilm Corporation · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −10 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −9 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −8 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −7 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −6 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −5 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −4 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −3 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| −2 | K131780 | Evis Exera Iii Video System | Olympus Medical Systems Corp. | 2013 | 8 |
| −1 | K222584 | Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus… | Olympus Medical Systems Corporation | 2023 | 1 |
| 0 (this device) | K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L… | Fujifilm Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
3 devices in this family have a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K172916 | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM…Summary page 5…876.1500 Product Code(s) FDF I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K172916 FUJIFILM Endoscope Model EC-760R-V/L FDF K190649 FUJIFILM Endoscope Model EC-760S-V/L FDF K183572 FUJIFILM Endoscope Models EC-76… | 2018 |
| * | K190649 | FUJIFILM Endoscope Model EC-760S-V/LSummary page 5…Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K172916 FUJIFILM Endoscope Model EC-760R-V/L FDF K190649 FUJIFILM Endoscope Model EC-760S-V/L FDF K183572 FUJIFILM Endoscope Models EC-760P-V/L FDF K222584 EVIS X1 VIDEO SYSTEM CENTER OL… | 2019 |
| * | K183572 | FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LSummary page 5…# Predicate Trade Name (Primary Predicate is listed first) Product Code K172916 FUJIFILM Endoscope Model EC-760R-V/L FDF K190649 FUJIFILM Endoscope Model EC-760S-V/L FDF K183572 FUJIFILM Endoscope Models EC-760P-V/L FDF K222584 EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLGQ | FET Device Description Sum… | 2019 |
| * | K222584 | Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I…Summary page 5…d first) Product Code K172916 FUJIFILM Endoscope Model EC-760R-V/L FDF K190649 FUJIFILM Endoscope Model EC-760S-V/L FDF K183572 FUJIFILM Endoscope Models EC-760P-V/L FDF K222584 EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLGQ | FET Device Description Summary 21 CFR 807.92(a)(4) A. Intended Use/indicati… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 5 generations back · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 6 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 22 of the 42 ancestors have a recall of any class; 3 have a Class I recall.
- 10 other devices also cite its predicate K172916.
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. 2025, 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 product 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243261: FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243261
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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