Cleared Traditional

K844099 - CANMED 102

K844099 is the FDA 510(k) clearance for CANMED 102 by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K844099 · Medtronic Vascular · Cardiovascular device
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Dec 1984
Decision
65d
Days
Class 2
Risk

K844099 is an FDA 510(k) clearance for the CANMED 102. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Medtronic Vascular (Lawrence, US). The FDA issued a Cleared decision on December 27, 1984 after a review of 65 days - a notably fast clearance 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: 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 Medtronic Vascular devices

Submission Details

510(k) Number K844099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date December 27, 1984
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
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 82
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K844099.
DISPOSABLE ECG MONITORING ELECTRODE
K863904 · Clinical Data, Inc. · Jan 1987
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
K861246 · Conmedcorp · Aug 1986
FOAM ECG ELECTRODES
K852177 · Clinical Data, Inc. · Aug 1985
CANMED 101
K844100 · Medtronic Vascular · Dec 1984
ESOPHOGRAL MULTIPROBE
K832903 · Vital Signs, Inc. · May 1984
MEDI-TRACE QUIKSET DX DIAG. ELECT-
K834445 · Graphic Controls Corp. · Apr 1984