Cleared Traditional

K060321 - ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK

K060321 is an FDA 510(k) clearance for ADSCOPE 657BK ELECTRONIC STETHOSCOPE, manufactured by American Diagnostic Corp.. The device is a Class 2 Chemistry device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K060321

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
Combination Product No
PCCP Authorized No
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.

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 Chemistry devices follow this clearance model.

Regulatory Peers - DQD Stethoscope, Electronic

All 132
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K060321.
RNK ELECTRONIC STETHOSCOPE
K072026 · Rnk Products, Inc. · Oct 2007
I-SCOPE 200
K062364 · Dongjin Medical Co., Ltd. · Dec 2006
SERENO ELECTRONIC STETHOSCOPE
K062481 · Pishon High Tech Co., Ltd. · Oct 2006
ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28
K060197 · Zargis Medical Corp. · Mar 2006
HEART STG SYSTEM AND SOFTWARE
K052283 · Stethographics, Inc. · Dec 2005
EXTENDED MEASUREMENTS SYSTEM
K051450 · Inovise Medical, Inc. · Nov 2005
K060321 · ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
Download PDF FDA Summary American Diagnostic C…