Cleared Traditional

K013725 - MEDITRON II THESTERTHOSCOPE SYSTEM

K013725 is an FDA 510(k) clearance for MEDITRON II THESTERTHOSCOPE SYSTEM, manufactured by Meditron AS. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K013725 · Meditron AS · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
82d
Days
Class 2
Risk

K013725 is an FDA 510(k) clearance for the MEDITRON II THESTERTHOSCOPE SYSTEM. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Meditron AS (Chapel Hill, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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 - K013725

510(k) Number K013725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2001
Decision Date January 30, 2002
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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 - DQD Stethoscope, Electronic

All 141
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K013725.
HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300
K021087 · Erecords Limited · Oct 2002
BIOLOGICAL SOUND MONITOR (BSM) SENSOR
K021389 · Andromed, Inc. · Oct 2002
I-STETHOS LINK
K022298 · Andromed, Inc. · Oct 2002
ADC 656 ELECTRONIC STETHOSCOPE
K012304 · American Diagnostic Corp. · Nov 2001
AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
K010729 · Andromed, Inc. · Oct 2001
E-STETH ELECTRONIC STETHOSCOPE
K011898 · E-Med Innovations, Inc. · Sep 2001
K013725 · MEDITRON II THESTERTHOSCOPE SYSTEM
Download PDF FDA Summary Meditron AS