Cleared Traditional

K001306 - STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX

K001306 is an FDA 510(k) clearance for STETHOS, manufactured by Andromed, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K001306 · Andromed, Inc. · Cardiovascular device
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Jul 2000
Decision
86d
Days
Class 2
Risk

K001306 is an FDA 510(k) clearance for the STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Andromed, Inc. (St.Laurent, Quebec, CA). The FDA issued a Cleared decision on July 20, 2000 after a review of 86 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 - K001306

510(k) Number K001306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2000
Decision Date July 20, 2000
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
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 127
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K001306.
EHC400 DESKTOP PATIENT STATION
K002984 · Cybercare Technologies, Inc. · Dec 2000
DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2
K002047 · Doctor'S Research Group, Inc. · Nov 2000
ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200
K001788 · Erecords Enterprises · Nov 2000
GEMINI E
K993623 · Allen Medical Instruments Corp. · Jun 2000
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
K991714 · Doctor'S Research Group, Inc. · Dec 1999
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
K991756 · Bio-Research Associates, Inc. · Dec 1999