Cleared Traditional

K152387 - Fluent Inflation Device

K152387 is an FDA 510(k) clearance for Fluent Inflation Device, manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K152387 · Vascular Solutions, Inc. · Cardiovascular device
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Dec 2015
Decision
116d
Days
Class 2
Risk

K152387 is an FDA 510(k) clearance for the Fluent Inflation Device. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 18, 2015 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vascular Solutions, Inc. devices

FDA 510(k) Submission Details - K152387

510(k) Number K152387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 24, 2015
Decision Date December 18, 2015
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAV Device Classification - Class 2, Special Controls

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MAV Syringe, Balloon Inflation

All 38
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K152387.
Fluent inflation device
K162272 · Vascular Solutions, Inc. · Oct 2016
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
K153038 · Medtronic, Inc. · Apr 2016
basixTOUCH40 Inflation Syringe
K153672 · Merit Medical Systems, Inc. · Jan 2016
Presto Inflation Device
K143522 · C.R. Bard, Inc. · Jan 2015
ENCORE 26 ADVANTAGE KIT
K140745 · Boston Scientific Corp · Apr 2014
BASIXTOUCH
K130566 · Merit Medical Systems, Inc. · Jun 2013