# K262152: VS-370CF, VS-370CT

- Pathway: 510(k) (Traditional)
- Applicant: VISION MEDICAL Co., Ltd.
- Decided: Jul 24, 2026 after 29 days
- Product code: FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope)
- 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: 13 generations back to K964171 (1997). 35 ancestors in all.
No later device cites it as a predicate yet.
3 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230474: EVA5 Insufflator, Palliare, Ltd. (2023) Summary page 5.

## Indications for use
The VS-370CT and VS-370CF are intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.

Source page: https://510kreport.com/device/K262152
Methodology: https://510kreport.com/methodology