Cleared Traditional

K032230 - RHYTHM DIGITAL ELECTRONIC STETHOSCOPE

K032230 is an FDA 510(k) clearance for RHYTHM DIGITAL ELECTRONIC STETHOSCOPE, manufactured by Thinklabs, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K032230 · Thinklabs, Inc. · Cardiovascular device
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Nov 2003
Decision
128d
Days
Class 2
Risk

K032230 is an FDA 510(k) clearance for the RHYTHM DIGITAL ELECTRONIC STETHOSCOPE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Thinklabs, Inc. (Sound Beach, US). The FDA issued a Cleared decision on November 26, 2003 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K032230

510(k) Number K032230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2003
Decision Date November 26, 2003
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
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 K032230.
MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)
K042128 · Zargis Medical Corp. · Sep 2004
ZARGIS ACOUSTIC CARDIOSCAN
K031517 · Zargis Medical Corp. · May 2004
RNK TELEPHONIC STETHOSCOPE, MODEL TR-1
K034046 · Rnk Products · Mar 2004
JABES ELECTRONIC STETHOSCOPE
K031446 · Gs Technology Co., Ltd. · Oct 2003
CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER
K023759 · Sonomedica · May 2003
TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)
K023637 · Tytan Medical Corp. · Feb 2003
K032230 · RHYTHM DIGITAL ELECTRONIC STETHOSCOPE
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