# K153672: basixTOUCH40 Inflation Syringe

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jan 20, 2016 after 30 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943597 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130566: Basixtouch, Merit Medical Systems, Inc. (2013) Summary page 4.

## Indications for use
The basixTOUCH40 Inflation Syringe is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

Source page: https://510kreport.com/device/K153672
Methodology: https://510kreport.com/methodology