# K083523: Monarch Compak Inflation Syringe and Universal Fluid Dispensing Syringe

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Feb 4, 2009 after 70 days
- Product code: DXT (Injector And Syringe, Angiographic)
- 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: 2 generations back to K943597 (1995). 4 ancestors in all.
4 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)
- K011811: Monarch Inflation Syringe; Universal Fluid Dispensing Syringe, Merit Medical Systems, Inc. (2001)
- K040138: Viceroy Inflation Device, Merit Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K122321: Basixconpak Analog Inflation Syringe (2012), 3 descendants of its own
- 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 19, 2024 · Class II · Z-0064-2025: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

## Indications for use
The Monarch™ COMPAK Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices, and to measure the pressure within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid.

Source page: https://510kreport.com/device/K083523
Methodology: https://510kreport.com/methodology