Cleared Special

K032466 - SPIDERVIEW

K032466 is the FDA 510(k) clearance for SPIDERVIEW by Ela Medical, Inc.. It is a Class 2 Cardiovascular device (product code MWJ) cleared through the Special 510(k) pathway after a 11-day FDA review.

K032466 · Ela Medical, Inc. · Cardiovascular device
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Aug 2003
Decision
11d
Days
Class 2
Risk

K032466 is an FDA 510(k) clearance for the SPIDERVIEW. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Ela Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ela Medical, Inc. devices

Submission Details

510(k) Number K032466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2003
Decision Date August 22, 2003
Days to Decision 11 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 125d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 14
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K032466.
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