Cleared Traditional

DOBE (MODIFIED) (K853993) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853993 · Phoenix Medical Technology, Inc. · Cardiovascular device
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Feb 1986
Decision
154d
Days
Class 2
Risk

K853993 is an FDA 510(k) clearance for the DOBE (MODIFIED). Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Phoenix Medical Technology, Inc. (Andrews, US). The FDA issued a Cleared decision on February 28, 1986 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 Phoenix Medical Technology, Inc. devices

Submission Details

510(k) Number K853993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1985
Decision Date February 28, 1986
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 23
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K853993.
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E
K874423 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E
K874424 · Hewlett-Packard Co. · Jan 1988
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK
K864868 · Hewlett-Packard Co. · Jan 1987
CANMED 102
K844099 · Medtronic Vascular · Dec 1984
CANMED 101
K844100 · Medtronic Vascular · Dec 1984
QUIK-SILVER RESTING ECG ELECTRODE
K830655 · Quinton, Inc. · Jun 1983