Cleared Traditional

K042469 - BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER

K042469 is an FDA 510(k) clearance for BRAEMAR ER800 SERIES ENHANCED ALGORITHM..., manufactured by Braemar, Inc.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K042469 · Braemar, Inc. · Cardiovascular device
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Oct 2004
Decision
23d
Days
Class 2
Risk

K042469 is an FDA 510(k) clearance for the BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Braemar, Inc. (Burnsville, US). The FDA issued a Cleared decision on October 6, 2004 after a review of 23 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 Braemar, Inc. devices

FDA 510(k) Submission Details - K042469

510(k) Number K042469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date October 06, 2004
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
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 23
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