Cleared Traditional

K034046 - RNK TELEPHONIC STETHOSCOPE, MODEL TR-1

K034046 is an FDA 510(k) clearance for RNK TELEPHONIC STETHOSCOPE, manufactured by Rnk Products. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K034046 · Rnk Products · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
72d
Days
Class 2
Risk

K034046 is an FDA 510(k) clearance for the RNK TELEPHONIC STETHOSCOPE, MODEL TR-1. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Rnk Products (Burnsville, US). The FDA issued a Cleared decision on March 10, 2004 after a review of 72 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 - K034046

510(k) Number K034046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2003
Decision Date March 10, 2004
Days to Decision 72 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
53d faster than avg
Panel avg: 125d · This submission: 72d
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 K034046.
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K041934 · 3M Company · Oct 2004
MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)
K042128 · Zargis Medical Corp. · Sep 2004
ZARGIS ACOUSTIC CARDIOSCAN
K031517 · Zargis Medical Corp. · May 2004
RHYTHM DIGITAL ELECTRONIC STETHOSCOPE
K032230 · Thinklabs, Inc. · Nov 2003
JABES ELECTRONIC STETHOSCOPE
K031446 · Gs Technology Co., Ltd. · Oct 2003
CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER
K023759 · Sonomedica · May 2003
K034046 · RNK TELEPHONIC STETHOSCOPE, MODEL TR-1
Download PDF FDA Summary Rnk Products