Cleared Abbreviated

K001288 - DR180-II (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K001288 · North East Monitoring, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
87d
Days
Class 2
Risk

K001288 is an FDA 510(k) clearance for the DR180-II. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by North East Monitoring, Inc. (Sudbury, US). The FDA issued a Cleared decision on July 20, 2000 after a review of 87 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.

View all North East Monitoring, Inc. devices

Submission Details

510(k) Number K001288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2000
Decision Date July 20, 2000
Days to Decision 87 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Standards-based clearance path.

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 58
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K001288.
HeartBeam AIMIGo(TM) System
K231424 · Heartbeam, Inc. · Dec 2024
ASSURE Wearable ECG
K233864 · Kestra Medical Technologies, Inc. · May 2024
Eclipse MINI Model 98900
K212317 · Spacelabs Healthcare, Ltd. · Nov 2022
Biotres
K222017 · Biotricity · Jul 2022
Q Patch
K210758 · Medicalgorithmics S.A. · Jun 2022
Biotres
K211709 · Biotricity · Jan 2022