# K040138: Viceroy Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Feb 13, 2004 after 22 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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) Boston Scientific's LeVeen Inflator Disposable Inflation Syringe: named in the summary without a submission number
- (no number) Guidant's Indeflator 20/30 Inflation Device: named in the summary without a submission number
- (no number) Wilson/Cook's Quantum Inflation Device: named in the summary without a submission number

## 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
- 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
- Oct 21, 2005 · Not classified · Z-0290-06: Inflation device may not hold vacuum during angioplasty procedure.
- Oct 21, 2005 · Not classified · Z-0291-06: Inflation device may not hold vacuum during angioplasty procedure.

## Indications for use
To inflate and deflate an angioplasty balloon or other interventional device and when equipped with a gauge, to monitor the pressure within the balloon.

Source page: https://510kreport.com/device/K040138
Methodology: https://510kreport.com/methodology