# K160107: DiamondTOUCH Inflation Device and Fluid Dispensing Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jul 29, 2016 after 192 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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) Summary page 4.

## Most influential descendants
- K260035: Digital Indeflator INFLANTE (2026), 0 descendants of its own

## Recalls of this device
- Aug 19, 2024 · Class II · Z-0066-2025: 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 DiamondTOUCH Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation 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/K160107
Methodology: https://510kreport.com/methodology