510(k) · Cleared
ClearedDouble Balloon Endoscope EN-840T, Over-tube TS-1214C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FUJIFILM Healthcare Americas Corporation · FDA Enteroscope And Accessories
Cleared on Jun 13, 2024 as substantially equivalent to K143556 (Fujifilm Medical Systems U.S.A, Inc., 2015) and 3 other predicates after a 258-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jun 13, 2024
- Review
- 258 days
- Class
- Class II
- Product code
- FDA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K993704 (2000). 16 ancestors in all, the oldest K944759 (1995). No later device cites it as a predicate yet.
- Root · 6 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 5 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 4 generations backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- 3 generations backK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015
- 2 generations backK183683 FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20…Fujifilm Corporation · 2019
- 1 generation backK223295 Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit…Fujifilm Corporaton · 2023
- This deviceK233321 Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −5 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −4 | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 | Fujinon, Inc. | 2009 | — |
| −3 | K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | Fujifilm Medical Systems U.S.A, Inc. | 2015 | — |
| −2 | K183683 | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 | Fujifilm Corporation | 2019 | — |
| −1 | K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D | Fujifilm Corporaton | 2023 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TSummary page 5…ber 876.1500 Product Code FDA I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-5§( | FDA K221551 FUJIFILM Endoscope Model EI-740D/S FDS K183032 FUJIFIL… | 2015 |
| * | K221551 | FUJIFILM Endoscope Model EI-740D/SSummary page 5…807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-5§( | FDA K221551 FUJIFILM Endoscope Model EI-740D/S FDS K183032 FUJIFILM Double Balloon Endoscope EI-580BT FDA K223295 Endoscope Model EN-580T, Ov… | 2023 |
| * | K183032 | FUJIFILM Double Balloon Endoscope EI580BTSummary page 5…Primary Predicate is listed first) Product Code K143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-5§( | FDA K221551 FUJIFILM Endoscope Model EI-740D/S FDS K183032 FUJIFILM Double Balloon Endoscope EI-580BT FDA K223295 Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS'AEI FDA Device Des… | 2019 |
| * | K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DSummary page 5…Fujifilm Double Balloon Endoscopes Models EN-530T and EN-5§( | FDA K221551 FUJIFILM Endoscope Model EI-740D/S FDS K183032 FUJIFILM Double Balloon Endoscope EI-580BT FDA K223295 Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS'AEI FDA Device Description Summary 21 CFR 807.92(a)(4) Technological cha… | 2023 |
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 24 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 16 ancestors have a recall of any class.
- 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. 2024, 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?
Double Balloon Endoscope Model EN-840T
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-1214C
This product is intended to be used as an accessory with the FUJIFILM Double Balloon Endoscope cleared for use with an Over-tube. The Over-tube is used to assist with the movement of the scope inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
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/K233321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233321: Double Balloon Endoscope EN-840T, Over-tube TS-1214C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233321
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