# K213195: Balloon BS-3

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Oct 29, 2021 after 30 days
- Product code: FDA (Enteroscope And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K993704 (2000). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T, Fujifilm Medical Systems U.S.A, Inc. (2015) Summary page 4.

## Most influential descendants
- K223295: Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (2023), 1 descendant of its own
- K233321: Double Balloon Endoscope  EN-840T, Over-tube TS-1214C (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K213195
Methodology: https://510kreport.com/methodology