510(k) · Cleared
ClearedFUJIFILM Double Balloon Endoscope EI580BT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · FDA Enteroscope And Accessories
Cleared on Jun 24, 2019 as substantially equivalent to K143556 (Fujifilm Medical Systems U.S.A, Inc., 2015) after a 235-day review. Its family tree reaches back 4 generations to 2000. 5 later devices descend from it.
- Decided
- Jun 24, 2019
- Review
- 235 days
- Class
- Class II
- Product code
- FDA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K993704 (2000). 7 ancestors in all, the oldest K944759 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 3 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 2 generations backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- 1 generation backK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015
- This deviceK183032 FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation · 2019
- Descendant · cites it directly · 3 of its ownK240142 FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T…Fujifilm Corporation · 2024
- Descendant · 2 generations on · 1 of its ownK243260 FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK261880 FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy…Fujifilm Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK243512 FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T…Fujifilm Corporation · 2025
- Descendant · cites it directly · 0 of its ownK233321 Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation · 2024
Most influential descendants
Showing 5 of 5 · See all- K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation · 2024 · cites it directly3descendants
- K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation · 2025 · 2 generations on1descendant
- K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation · 2026 · 3 generations on0descendants
- K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation · 2025 · 2 generations on0descendants
- K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −3 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K183032 | FUJIFILM Double Balloon Endoscope EI580BT | Fujifilm Corporation | 2019 | — |
| +1 | K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM… | Fujifilm Corporation | 2024 | — |
| +2 | K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Fujifilm Corporation | 2025 | — |
| +3 | K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program… | Fujifilm Corporation | 2026 | — |
| +2 | K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM… | Fujifilm Corporation | 2025 | — |
| +1 | K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | FUJIFILM Healthcare Americas Corporation | 2024 | — |
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 |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 FDA? 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 FDA device
- #1 K260314 Ancora-SBscore 13.4 · 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 |
|---|---|---|---|
| * | K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TSummary page 4…CFR 876.1500 FDF Gastroscope And Accessories, Flexible/Rigid 21 CFR 876.1500 FDS Predicate Device: FUJIFILM Double Balloon Endoscope Model EN-580T (K143556) Reference Devices: FUJIFILM Endoscope Model EC-760R-V/L (K172916) 047… | 2015 |
| † | K172916 | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM… | 2018 |
What descends from it? (5)
2 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 19 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K240142 (Fujifilm Corporation, 2024) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K143556.
How does its category compare?
All FDA devicesFDA Enteroscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FDA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDA
Too few FDA 510(k)s in any year since 2007 to give a median.
Recalls per year · FDA
No recall names FDA since 2007.
Adverse event reports per year · FDA
116in 2025
MAUDE reports naming product code FDA, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 81 |
| 2019 | 2 | — | 0 | 76 |
| 2020 | 1 | — | 0 | 29 |
| 2021 | 1 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 87 |
| 2023 | 2 | — | 0 | 72 |
| 2024 | 1 | — | 0 | 86 |
| 2025 | 1 | — | 0 | 116 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183032 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183032: FUJIFILM Double Balloon Endoscope EI580BT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183032
Report an extraction error
Are you the manufacturer?
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