Cleared Traditional

K801802 - ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE

K801802 is the FDA 510(k) clearance for ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE by Medical Testing System, Inc.. It is a Class 2 Cardiovascular device (product code DPW) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K801802 · Medical Testing System, Inc. · Cardiovascular device
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Jan 1981
Decision
157d
Days
Class 2
Risk

K801802 is an FDA 510(k) clearance for the ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Medical Testing System, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 2, 1981 after a review of 157 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 Medical Testing System, Inc. devices

Submission Details

510(k) Number K801802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1980
Decision Date January 02, 1981
Days to Decision 157 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
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 35
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K801802.
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