Cleared Traditional

K123658 - BIOMODULE 3-M1

K123658 is an FDA 510(k) clearance for BIOMODULE 3-M1, manufactured by Zephyr Technology Corporation. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K123658 · Zephyr Technology Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
147d
Days
Class 2
Risk

K123658 is an FDA 510(k) clearance for the BIOMODULE 3-M1. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Zephyr Technology Corporation (Stamford, US). The FDA issued a Cleared decision on April 24, 2013 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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.

FDA 510(k) Submission Details - K123658

510(k) Number K123658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2012
Decision Date April 24, 2013
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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.

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All 234
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