# K011811: Monarch Inflation Syringe; Universal Fluid Dispensing Syringe

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Aug 22, 2001 after 72 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943597 (1995). 2 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943597: Monarch AP (TM), Merit Medical Systems, Inc. (1995) Summary page 1.
- K973230: Monarch (in 2125)/Intellisystem (in 1125), Merit Medical Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- K083523: Monarch Compak Inflation Syringe and Universal Fluid Dispensing Syringe (2009), 4 descendants of its own
- K122321: Basixconpak Analog Inflation Syringe (2012), 3 descendants of its own
- K130566: Basixtouch (2013), 2 descendants of its own
- K160107: DiamondTOUCH Inflation Device and Fluid Dispensing Syringe (2016), 1 descendant of its own
- K260035: Digital Indeflator INFLANTE (2026), 0 descendants of its own

## Recalls of this device
- Aug 30, 2024 · Class II · Z-0059-2025: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
- Aug 30, 2024 · Class II · Z-0060-2025: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
- Aug 30, 2024 · Class II · Z-0061-2025: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
- Aug 30, 2024 · Class II · Z-0057-2025: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
- Aug 30, 2024 · Class II · Z-0058-2025: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
- Aug 30, 2024 · Class II · Z-0062-2025: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
- Aug 19, 2024 · Class II · Z-0069-2025: 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.
- Mar 23, 2011 · Not classified · Z-3175-2011: Device was shipped past the labeled expiration date.
- Oct 13, 2003 · Not classified · Z-0146-04: Devices for which sterility may be compromised as evidenced by a loss of package integrity.
- Oct 1, 2003 · Not classified · Z-0137-04: There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or 

## Indications for use
The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.

Source page: https://510kreport.com/device/K011811
Methodology: https://510kreport.com/methodology