Cleared Traditional

K820579 - FLEX-E1 ECG ELECTRODE

K820579 is an FDA 510(k) clearance for FLEX-E1 ECG ELECTRODE, manufactured by Conmedcorp. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K820579 · Conmedcorp · Cardiovascular device
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Apr 1982
Decision
42d
Days
Class 2
Risk

K820579 is an FDA 510(k) clearance for the FLEX-E1 ECG ELECTRODE. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Conmedcorp (Dayton, US). The FDA issued a Cleared decision on April 14, 1982 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conmedcorp devices

FDA 510(k) Submission Details - K820579

510(k) Number K820579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1982
Decision Date April 14, 1982
Days to Decision 42 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRS Device Classification - Class 2, Special Controls

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 89
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K820579.
DISPOSABLE BLOOD PRESSURE TRANSDUCER
K821416 · Bentley Laboratories, Inc. · Jul 1982
VIRAGARD/VIRASHIELD
K820459 · Tri-Med, Inc. · Jun 1982
PRESSURE TUBING-ADULT & PEDIATRIC
K821450 · Gould, Inc. · May 1982
TOUCH FLUSH W/Y TRANSDUCER CONNECTOR
K820676 · Norton Performance Plastics Corp. · Mar 1982
TOUCH FLUSH CONTINUOUS FAST/FLUSH
K820677 · Norton Performance Plastics Corp. · Mar 1982
MEDI-TRACE PHYSIOLOGICAL PRESSURE TRANS
K820457 · Graphic Controls Corp. · Mar 1982