# K130566: Basixtouch

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jun 19, 2013 after 107 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: 4 generations back to K943597 (1995). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122321: Basixconpak Analog Inflation Syringe, Merit Medical Ireland, Ltd. (2012) Summary page 1.

## Most influential descendants
- K153672: basixTOUCH40 Inflation Syringe (2016), 0 descendants of its own
- K140943: Mastro Plus Balloon in-Deflation Device (2015), 0 descendants of its own

## Indications for use
The basixTOUCH 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/K130566
Methodology: https://510kreport.com/methodology