510(k) · Cleared
ClearedFUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Jul 2, 2026 as substantially equivalent to K243260 (Fujifilm Corporation, 2025) and 2 other predicates after a 27-day review. Its family tree reaches back 12 generations to 1993. 3 of the 57 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 2, 2026
- Review
- 27 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K931154 (1993). 56 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 3 of the 57 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations between
- 3 generations backK122831 Video System CenterOlympus Medical Systems Corp. · 2012
- 2 generations backK163675 Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
- 1 generation backK243260 FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation · 2025
- This deviceK261880 FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy…Fujifilm Corporation · 2026
Show all 12 generations
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 11 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 10 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 9 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 8 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 7 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 6 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 5 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 4 generations backK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
- 3 generations backK122831 Video System CenterOlympus Medical Systems Corp. · 2012
- 2 generations backK163675 Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
- 1 generation backK243260 FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation · 2025
- This deviceK261880 FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy…Fujifilm Corporation · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −11 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −10 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −9 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −8 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −7 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −6 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −5 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −4 | K112680 | Evis Exera Iii Video System | Olympus Medical Systems Corporation | 2012 | 6 |
| −3 | K122831 | Video System Center | Olympus Medical Systems Corp. | 2012 | — |
| −2 | K163675 | Processor VP-7000, Light Source BL-7000 | Fujifilm Medical System U.S.A., Inc. | 2017 | — |
| −1 | K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Fujifilm Corporation | 2025 | — |
| 0 (this device) | K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program… | Fujifilm Corporation | 2026 | — |
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 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K243260 FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model FET EG-860R K1534… | 2025 |
| * | K153483 | Balloon controller PB-30Summary page 5…isted first) Product Code K243260 FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model FET EG-860R K153483 Balloon controller PB-30 FDF K223827 FUJIFILM Endo… | 2015 |
| * | K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01Summary page 5…LM Endoscope Model FET EG-860R K153483 Balloon controller PB-30 FDF K223827 FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support FDF Program EW10-V… | 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 · 7 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 20 of the 56 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
Processor EP-8000 The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation…
Read the full statement (187 words)
Processor EP-8000
The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment. BLI (Blue Light Imaging), LCI (Linked Color Imaging), ACI (Amber-red Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI, ACI and FICE are not intended to replace histopathological sampling as a means of diagnosis.
PB-30
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over-tube insertion. This product is not intended for use for any neonates, infants or children.
EW10-VM01
This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. This software provides no therapeutic or diagnostic function.
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/K261880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261880: FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261880
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026