Cleared Traditional

K811246 - DOPPLER ULTRASOUND BLOOD FLOWMETER

K811246 is an FDA 510(k) clearance for DOPPLER ULTRASOUND BLOOD FLOWMETER, manufactured by Irex Corp.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K811246 · Irex Corp. · Cardiovascular device
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Aug 1981
Decision
99d
Days
Class 2
Risk

K811246 is an FDA 510(k) clearance for the DOPPLER ULTRASOUND BLOOD FLOWMETER. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Irex Corp. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1981 after a review of 99 days - within the typical 510(k) review window.

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 Irex Corp. devices

FDA 510(k) Submission Details - K811246

510(k) Number K811246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1981
Decision Date August 12, 1981
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

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 81
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K811246.
PERIFLUX PF-2
K844631 · Medex, Inc. · Feb 1985
XOMED PATENCY MONITOR
K821373 · Xomed, Inc. · Jul 1982
NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100
K820742 · Nihon Kohden America, Inc. · Apr 1982
EMIT TOBRAMYCIN CONTROL
K800151 · Syva Co. · Feb 1980
BLOOD FLOWMETER SYSTEM
K780302 · Medtronic Vascular · Apr 1978