Cleared Traditional

K905446 - MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE

K905446 is an FDA 510(k) clearance for MEDITRONIC ANDOVER MEDICAL MODEL 1690 E..., manufactured by Medtronic Andover Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K905446 · Medtronic Andover Medical, Inc. · Cardiovascular device
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Feb 1991
Decision
62d
Days
Class 2
Risk

K905446 is an FDA 510(k) clearance for the MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Medtronic Andover Medical, Inc. (Haverhill, US). The FDA issued a Cleared decision on February 5, 1991 after a review of 62 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.

FDA 510(k) Submission Details - K905446

510(k) Number K905446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1990
Decision Date February 05, 1991
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

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 328
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K905446.
RESTING EKG ELECTRODE SERIES
K910494 · Medtronic Andover Medical, Inc. · Apr 1991
VER-MED A10017 UNIVERSAL ELECTRODE
K905489 · Vermont Medical, Inc. · Mar 1991
CANMED 451
K905729 · Andover Medical, Inc. · Feb 1991
TRACET AG 4000
K904512 · Lectec Corp. · Jan 1991
MONITRODE
K903491 · Lleventon · Dec 1990
ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC.
K903555 · Jason Marketing Co. · Nov 1990
K905446 · MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE
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