Cleared Special

K192966 - FlowMet

K192966 is the FDA 510(k) clearance for FlowMet by Laser Associated Sciences, Inc.. It is a Class 2 Cardiovascular device (product code DPW) cleared through the Special 510(k) pathway after a 79-day FDA review.

K192966 · Laser Associated Sciences, Inc. · Cardiovascular device
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Jan 2020
Decision
79d
Days
Class 2
Risk

K192966 is an FDA 510(k) clearance for the FlowMet. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Laser Associated Sciences, Inc. (Irvine, US). The FDA issued a Cleared decision on January 10, 2020 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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 Laser Associated Sciences, Inc. devices

Submission Details

510(k) Number K192966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2019
Decision Date January 10, 2020
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 33
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