Cleared Traditional

K992584 - PE 501 PC-ECG MONITOR

K992584 is an FDA 510(k) clearance for PE 501 PC-ECG MONITOR, manufactured by Nhe Corp.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K992584 · Nhe Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
164d
Days
Class 2
Risk

K992584 is an FDA 510(k) clearance for the PE 501 PC-ECG MONITOR. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Nhe Corp. (Richmond, US). The FDA issued a Cleared decision on January 13, 2000 after a review of 164 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Nhe Corp. devices

FDA 510(k) Submission Details - K992584

510(k) Number K992584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1999
Decision Date January 13, 2000
Days to Decision 164 days
Submission Type Traditional
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
39d slower than avg
Panel avg: 125d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 27
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K992584.
SPIDERVIEW
K032466 · Ela Medical, Inc. · Aug 2003
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
K021470 · General Electric Medical Systems Information Techn · Nov 2002
H12+HOLTER RECORDER
K021373 · Mortara Instrument, Inc. · Jun 2002
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
K993643 · Nexan Telemed , Ltd. · Dec 1999
DIGITRAKPLUS HOLTER RECORDER
K993617 · Braemar Corp. · Nov 1999
DXP1000 HOLTER RECORDER
K993618 · Braemar Corp. · Nov 1999