Cleared Special

K140102 - PHYSIOFLOW Q-LINK

K140102 is an FDA 510(k) clearance for PHYSIOFLOW Q-LINK, manufactured by Vasocom, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Special 510(k) pathway after a 28-day FDA review.

K140102 · Vasocom, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Feb 2014
Decision
28d
Days
Class 2
Risk

K140102 is an FDA 510(k) clearance for the PHYSIOFLOW Q-LINK. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Vasocom, Inc. (Bristol, US). The FDA issued a Cleared decision on February 12, 2014 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vasocom, Inc. devices

FDA 510(k) Submission Details - K140102

510(k) Number K140102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2014
Decision Date February 12, 2014
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 - DSB Plethysmograph, Impedance

All 22
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K140102.
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