# K162272: Fluent inflation device

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Oct 20, 2016 after 69 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
Longest line of descent: 6 generations back to K854261 (1985). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152387: Fluent Inflation Device, Vascular Solutions, Inc. (2015) Summary page 4.

## Indications for use
The Fluent inflation device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

Source page: https://510kreport.com/device/K162272
Methodology: https://510kreport.com/methodology