Cleared Traditional

K082771 - PROTRON TECHNOLOGIES, LLC STETHOTRON

K082771 is an FDA 510(k) clearance for PROTRON TECHNOLOGIES, manufactured by Protron Technologies, LLC. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K082771 · Protron Technologies, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
158d
Days
Class 2
Risk

K082771 is an FDA 510(k) clearance for the PROTRON TECHNOLOGIES, LLC STETHOTRON. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Protron Technologies, LLC (Leonia, US). The FDA issued a Cleared decision on February 27, 2009 after a review of 158 days - an extended review 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: 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 - K082771

510(k) Number K082771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2008
Decision Date February 27, 2009
Days to Decision 158 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 125d · This submission: 158d
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 K082771.
SIGNAL
K090493 · Zargis Medical Corp. · Aug 2009
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
K083903 · 3M Company · Jul 2009
SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM
K082528 · Noble Anesthesia-Air, Inc. · Mar 2009
ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33
K083309 · Zargis Medical Corp. · Feb 2009
TR-USB TELEPHONIC STETHOSCOPE
K081032 · Rnk Products, Inc. · Jun 2008
AUSCO ES-3100
K070550 · Koratek Company, Ltd. · Nov 2007
K082771 · PROTRON TECHNOLOGIES, LLC STETHOTRON
Download PDF FDA Summary Protron Technologies,…