Cleared Abbreviated

K041901 - SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER

K041901 is an FDA 510(k) clearance for SD360 DIGITAL RECORDER/SD360 HOLTER DIG..., manufactured by North East Monitoring, Inc.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Abbreviated 510(k) pathway after a 48-day FDA review.

K041901 · North East Monitoring, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
48d
Days
Class 2
Risk

K041901 is an FDA 510(k) clearance for the SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by North East Monitoring, Inc. (Shelton, US). The FDA issued a Cleared decision on August 31, 2004 after a review of 48 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K041901

510(k) Number K041901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2004
Decision Date August 31, 2004
Days to Decision 48 days
Submission Type Abbreviated
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
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Standards-based clearance path.

MWJ Device Classification - Class 2, Special Controls

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 63
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K041901.
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