Cleared Traditional

K102723 - MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS

K102723 is an FDA 510(k) clearance for MODEL 950-12L HOLTER RECORDER WITHOUT A..., manufactured by Memtec Corp.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K102723 · Memtec Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K102723

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
Combination Product No
PCCP Authorized No
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.

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 K102723.
INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
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BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
K100310 · BTL Industries, Inc. · Oct 2010
ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603
K100266 · Camntech, Ltd. · Apr 2010
CHROMA, MODEL: RZ153C
K083382 · Scottcare Corporation · Aug 2009
K102723 · MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
Download PDF FDA Summary Memtec Corp.