Cleared Traditional

MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS (K102723) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102723 · Memtec Corp. · Cardiovascular device
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Dec 2010
Decision
79d
Days
Class 2
Risk

K102723 is an FDA 510(k) clearance for the MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Memtec Corp. (Salem, US). The FDA issued a Cleared decision on December 9, 2010 after a review of 79 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 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 Memtec Corp. devices

Submission Details

510(k) Number K102723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2010
Decision Date December 09, 2010
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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