510(k) · Cleared
ClearedBalloon BS-3
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 Oct 29, 2021 as substantially equivalent to K143556 (Fujifilm Medical Systems U.S.A, Inc., 2015) after a 30-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.
- Decided
- Oct 29, 2021
- Review
- 30 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). 2 later devices descend from it, 1 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 deviceK213195 Balloon BS-3Fujifilm Corporation · 2021
- Descendant · cites it directly · 1 of its ownK223295 Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit…Fujifilm Corporaton · 2023
- Descendant · 2 generations on · 0 of its ownK233321 Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation · 2024
Most influential descendants
Showing 2 of 2 · See allView 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) | K213195 | Balloon BS-3 | Fujifilm Corporation | 2021 | — |
| +1 | K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D | Fujifilm Corporaton | 2023 | — |
| +2 | 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 |
|---|---|---|
| 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.
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…Endoscope and accessories Device Panel: Gastroenterology/Urology Product Code: FDA Predicate Devices: • Balloon BS-2 (K143556) Intended Use / Indications for Use Balloon BS-3 is intended to be used in combination with FUJIFILM double balloon endoscopes… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D | 2023 | 1 |
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 21 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K223295 (Fujifilm Corporaton, 2023) has gone furthest, with 1 descendant 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. 2021, 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?
Balloon BS-3 is intended to be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract at medical facilities under the management of physicians.
Do not use this product for any other purpose. It is not intended for use for any neonates, infants or children.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213195 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213195: Balloon BS-3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213195
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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