Cleared Traditional

K060321 - ADSCOPE 657BK ELECTRONIC STETHOSCOPE

K060321 is the FDA 510(k) clearance for ADSCOPE 657BK ELECTRONIC STETHOSCOPE by American Diagnostic Corp.. It is a Class 2 Chemistry device (product code DQD) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K060321 · American Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
95d
Days
Class 2
Risk

K060321 is an FDA 510(k) clearance for the ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Hauppauge, US). The FDA issued a Cleared decision on May 15, 2006 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 870.1875 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all American Diagnostic Corp. devices

Submission Details

510(k) Number K060321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2006
Decision Date May 15, 2006
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DQD Stethoscope, Electronic

All 54
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