Cleared Traditional

K132405 - PPA/BT-RB STETHOSCOPE

K132405 is an FDA 510(k) clearance for PPA/BT-RB 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 70-day FDA review.

K132405 · Rnk Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
70d
Days
Class 2
Risk

K132405 is an FDA 510(k) clearance for the PPA/BT-RB STETHOSCOPE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Rnk Products, Inc. (Melbourne, US). The FDA issued a Cleared decision on October 11, 2013 after a review of 70 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 - K132405

510(k) Number K132405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2013
Decision Date October 11, 2013
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
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 K132405.
AbStats Gateway
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PARACE MD EKOSCOPE IS100
K123148 · Parace, LLC · Nov 2013
PCP-USB STETHOSCOPE
K132560 · Rnk Products, Inc. · Oct 2013
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
K131044 · Diacoustic Medical Devices (Pty) , Ltd. · Sep 2013
CARDIOSLEEVE
K131287 · Rijuven Corp · Jun 2013
K132405 · PPA/BT-RB STETHOSCOPE
Download PDF FDA Summary Rnk Products, Inc.