Cleared Traditional

K854596 - TDK ECG ELECTRODE MEL-08-09 & -11

K854596 is the FDA 510(k) clearance for TDK ECG ELECTRODE MEL-08-09 & -11 by Tdk Corp.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K854596 · Tdk Corp. · Cardiovascular device
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May 1986
Decision
170d
Days
Class 2
Risk

K854596 is an FDA 510(k) clearance for the TDK ECG ELECTRODE MEL-08-09 & -11. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Tdk Corp. (272 01, Japan, JP). The FDA issued a Cleared decision on May 7, 1986 after a review of 170 days - an extended review 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: 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 Tdk Corp. devices

Submission Details

510(k) Number K854596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date May 07, 1986
Days to Decision 170 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 125d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 71
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K854596.
SHELF LIFE CHANGE OF STERILE DEVICES
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APM DISPOS. BLOOD PRESSURE TRANSDUCER
K851888 · Honeywell, Inc. · Aug 1985
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K843273 · Hewlett-Packard Co. · Jun 1985