Cleared Traditional

K081032 - TR-USB TELEPHONIC STETHOSCOPE

K081032 is an FDA 510(k) clearance for TR-USB TELEPHONIC STETHOSCOPE, manufactured by Rnk Products, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K081032 · Rnk Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
56d
Days
Class 2
Risk

K081032 is an FDA 510(k) clearance for the TR-USB TELEPHONIC STETHOSCOPE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Rnk Products, Inc. (Burnsville, US). The FDA issued a Cleared decision on June 6, 2008 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K081032

510(k) Number K081032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2008
Decision Date June 06, 2008
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 132
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K081032.
SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM
K082528 · Noble Anesthesia-Air, Inc. · Mar 2009
PROTRON TECHNOLOGIES, LLC STETHOTRON
K082771 · Protron Technologies, LLC · Feb 2009
ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33
K083309 · Zargis Medical Corp. · Feb 2009
AUSCO ES-3100
K070550 · Koratek Company, Ltd. · Nov 2007
RNK ELECTRONIC STETHOSCOPE
K072026 · Rnk Products, Inc. · Oct 2007
I-SCOPE 200
K062364 · Dongjin Medical Co., Ltd. · Dec 2006
K081032 · TR-USB TELEPHONIC STETHOSCOPE
Download PDF FDA Summary Rnk Products, Inc.