510(k) · Cleared
ClearedEndoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporaton · FDA Enteroscope And Accessories
Cleared on Jan 11, 2023 as substantially equivalent to K183683 (Fujifilm Corporation, 2019) and 2 other predicates after a 77-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Jan 11, 2023
- Review
- 77 days
- Class
- Class II
- Product code
- FDA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K993704 (2000). 9 ancestors in all, the oldest K944759 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 4 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 3 generations backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- 2 generations backK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015
- 1 generation backK183683 FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20…Fujifilm Corporation · 2019
- This deviceK223295 Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit…Fujifilm Corporaton · 2023
- 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 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −5 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −4 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −3 | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 | Fujinon, Inc. | 2009 | — |
| −2 | K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | Fujifilm Medical Systems U.S.A, Inc. | 2015 | — |
| −1 | K183683 | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 | Fujifilm Corporation | 2019 | — |
| 0 (this device) | K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D | Fujifilm Corporaton | 2023 | — |
| +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 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (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 |
|---|---|---|---|
| * | K183683 | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Summary page 4…Endoscope and Accessories Review Panel: Gastroenterology/Urology Predicate Device(s): • FUJIFILM Double Balloon Endoscope EN-580T (K183683) • Over-tube TS-13140 (K143556) • Balloon BS-3 (K213195) • Tube Kit TY-06D (K143556) Intended Use / Indicatio… | 2019 |
| * | K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TSummary page 4…Review Panel: Gastroenterology/Urology Predicate Device(s): • FUJIFILM Double Balloon Endoscope EN-580T (K183683) • Over-tube TS-13140 (K143556) • Balloon BS-3 (K213195) • Tube Kit TY-06D (K143556) Intended Use / Indications for Use: Endoscope EN-580T This d… | 2015 |
| * | K213195 | Balloon BS-3Summary page 4…Gastroenterology/Urology Predicate Device(s): • FUJIFILM Double Balloon Endoscope EN-580T (K183683) • Over-tube TS-13140 (K143556) • Balloon BS-3 (K213195) • Tube Kit TY-06D (K143556) Intended Use / Indications for Use: Endoscope EN-580T This device is intended for the visua… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | 2024 | 0 |
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 4 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K233321 (FUJIFILM Healthcare Americas Corporation, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FDA devicesFDA Enteroscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Endoscope EN-580T 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. Never use this product for any other purposes. Over-tube TS-1314B This product is used in combination with a FUJIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the…
Read the full statement (217 words)
Endoscope EN-580T
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.
Never use this product for any other purposes.
Over-tube TS-1314B
This product is used in combination with a FUJIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities.
This product is used to assist with the movement of the scopes inside the upper or lower digestive tract.
Do not use this product for any other purposes.
This product is not intended for use for any neonates, infants or children.
Balloon BS-4
This product is used in combination with FUJIFILM Double Balloon Endoscopes at medical facilities under the management of physicians.
Being attached to the endoscope, this product is inserted into the digestive tract from the mouth or anus to stabilize the distal end of the endoscope to the digestive tract's mucous membrane.
Do not use this product for any other purposes.
This product is not intended for use for any neonates, infants or children.
Tube Kit TY-500D
This product is the tube kit used in combination with the compatible balloon controller in medical facilities.
Do not use this product for any other purpose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223295: Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223295
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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