Cleared Traditional

K182494 - FlowMet-R

K182494 is the FDA 510(k) clearance for FlowMet-R by Laser Associated Sciences, Inc.. It is a Class 2 Cardiovascular device (product code DPW) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K182494 · Laser Associated Sciences, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
169d
Days
Class 2
Risk

K182494 is an FDA 510(k) clearance for the FlowMet-R. 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 February 27, 2019 after a review of 169 days - an extended review cycle.

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

Submission Details

510(k) Number K182494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2018
Decision Date February 27, 2019
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K182494.
FlowMet
K192966 · Laser Associated Sciences, Inc. · Jan 2020
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
K183574 · Huntleigh Healthcare , Ltd. · Sep 2019
FloPatch (FP110)
K191388 · Flosonics Medical (R/A 1929803 Ontario Corp.) · Jun 2019
iCertainty
K181269 · Rfpi · Dec 2018
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
K172457 · Deltex Medical Limited · Jun 2018
MONITOR, MODEL HSM-00200
K031153 · Arrow Intl., Inc. · Nov 2003