Cleared Special

K130566 - BASIXTOUCH

K130566 is an FDA 510(k) clearance for BASIXTOUCH, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Special 510(k) pathway after a 107-day FDA review.

K130566 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
107d
Days
Class 2
Risk

K130566 is an FDA 510(k) clearance for the BASIXTOUCH. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on June 19, 2013 after a review of 107 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K130566

510(k) Number K130566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2013
Decision Date June 19, 2013
Days to Decision 107 days
Submission Type Special
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
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

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 55
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K130566.
Presto Inflation Device
K143522 · C.R. Bard, Inc. · Jan 2015
SUMMED INFLATION DEVICE KIT
K133795 · Sunny Medical Device (Shenzhen) Co., Ltd. · Dec 2014
ENCORE 26 ADVANTAGE KIT
K140745 · Boston Scientific Corp · Apr 2014
BASIXCONPAK ANALOG INFLATION SYRINGE
K122321 · Merit Medical Ireland, Ltd. · Dec 2012
OXTI INFLATION DEVICE
K122152 · Oxti Corporation · Dec 2012
ENCORE 26 ADVANTAGE KIT
K123214 · Boston Scientific Corp · Nov 2012
K130566 · BASIXTOUCH
Download PDF FDA Summary Merit Medical Systems…