Cleared Traditional

K072026 - RNK ELECTRONIC STETHOSCOPE

K072026 is an FDA 510(k) clearance for RNK ELECTRONIC 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 94-day FDA review.

K072026 · Rnk Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
94d
Days
Class 2
Risk

K072026 is an FDA 510(k) clearance for the RNK ELECTRONIC 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 October 26, 2007 after a review of 94 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 - K072026

510(k) Number K072026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2007
Decision Date October 26, 2007
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 K072026.
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
I-SCOPE 200
K062364 · Dongjin Medical Co., Ltd. · Dec 2006
SERENO ELECTRONIC STETHOSCOPE
K062481 · Pishon High Tech Co., Ltd. · Oct 2006
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
K060321 · American Diagnostic Corp. · May 2006
K072026 · RNK ELECTRONIC STETHOSCOPE
Download PDF FDA Summary Rnk Products, Inc.