# K943597: Monarch AP (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Feb 10, 1995 after 202 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
No predicates in its family tree.
9 later devices descend from it; 1 cites 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K943597
Methodology: https://510kreport.com/methodology