Cleared Traditional

K905729 - CANMED 451

K905729 is an FDA 510(k) clearance for CANMED 451, manufactured by Andover Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K905729 · Andover Medical, Inc. · Cardiovascular device
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Feb 1991
Decision
45d
Days
Class 2
Risk

K905729 is an FDA 510(k) clearance for the CANMED 451. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Andover Medical, Inc. (Haverhill, US). The FDA issued a Cleared decision on February 7, 1991 after a review of 45 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 Andover Medical, Inc. devices

FDA 510(k) Submission Details - K905729

510(k) Number K905729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1990
Decision Date February 07, 1991
Days to Decision 45 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
80d faster than avg
Panel avg: 125d · This submission: 45d
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 153
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