Cleared Traditional

K001306 - STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001306 · Andromed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Andromed, Inc. devices

Submission Details

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
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.

Device Classification

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 152
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K001306.
Tyto Stethoscope (G3)
K252089 · Tyto Care , Ltd. · Mar 2026
Kneevoice Cartilage Evaluation System (750-3600-001)
K252076 · Kneevoice, Inc. · Feb 2026
eMurmur Heart AI
K252284 · Csd Labs · Dec 2025
Stethophone Pro
K252595 · Sparrow Acoustics, Inc. · Sep 2025
Eko Foundation Analysis Software with Transformers (EFAST)
K251494 · Eko Health, Inc. · Aug 2025
AccurSound Electronic Stethoscope (AS101)
K242971 · Heroic Faith International , Ltd. · Nov 2024