# K973230: Monarch (in 2125)/Intellisystem (in 1125)

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Nov 25, 1997 after 90 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Merit Medical Medallion Syringe: named in the summary without a submission number

## Most influential descendants
- K011811: Monarch Inflation Syringe; Universal Fluid Dispensing Syringe (2001), 8 descendants of its own
- 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

## Recalls of this device
- Feb 13, 2003 · Not classified · Z-0620-03: A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
- Feb 13, 2003 · Not classified · Z-0621-03: A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
- Feb 13, 2003 · Not classified · Z-0622-03: A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.

## Indications for use
The Universal Fluid Dispensing Syringe is Merit Medical’s Monarch Syringe and Intellisystem Syringe intended to be used by healthcare professionals to inject fluids into the body and monitor the pressure of that fluid.

Source page: https://510kreport.com/device/K973230
Methodology: https://510kreport.com/methodology