Cleared Traditional

K100531 - VISCOPE, MODEL 100P,100S

K100531 is an FDA 510(k) clearance for VISCOPE, manufactured by Hd Medical Services (India) Pvt.Ltd. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K100531 · Hd Medical Services (India) Pvt.Ltd · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
147d
Days
Class 2
Risk

K100531 is an FDA 510(k) clearance for the VISCOPE, MODEL 100P,100S. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Hd Medical Services (India) Pvt.Ltd (San Diego, US). The FDA issued a Cleared decision on July 21, 2010 after a review of 147 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 - K100531

510(k) Number K100531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2010
Decision Date July 21, 2010
Days to Decision 147 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 125d · This submission: 147d
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 K100531.
A SCOPE
K103499 · Active Signal Technologies, Inc. · Mar 2011
AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0
K103516 · Inovise Medical, Inc. · Feb 2011
PCP/PC STETHOSCOPE
K102893 · Rnk Products, Inc. · Jan 2011
MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01
K091972 · Stethoscope Technologies, Inc. · Sep 2009
SIGNAL
K090493 · Zargis Medical Corp. · Aug 2009
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
K083903 · 3M Company · Jul 2009
K100531 · VISCOPE, MODEL 100P,100S
Download PDF FDA Summary Hd Medical Services (…