# K122321: Basixconpak Analog Inflation Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Ireland, Ltd.
- Decided: Dec 19, 2012 after 140 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943597 (1995). 5 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K083523: Monarch Compak Inflation Syringe and Universal Fluid Dispensing Syringe, Merit Medical Systems, Inc. (2009) Summary page 1.

## Most influential descendants
- K130566: Basixtouch (2013), 2 descendants of its own
- K153672: basixTOUCH40 Inflation Syringe (2016), 0 descendants of its own
- K140943: Mastro Plus Balloon in-Deflation Device (2015), 0 descendants of its own

## Recalls of this device
- Aug 25, 2016 · Class II · Z-0002-2017: Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.

## Indications for use
The Merit analog 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/K122321
Methodology: https://510kreport.com/methodology