Cleared Traditional

K160016 - Steth IO

K160016 is an FDA 510(k) clearance for Steth IO, manufactured by Stratoscientific, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K160016 · Stratoscientific, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
192d
Days
Class 2
Risk

K160016 is an FDA 510(k) clearance for the Steth IO. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Stratoscientific, Inc. (Shoreline, US). The FDA issued a Cleared decision on July 15, 2016 after a review of 192 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.

View all Stratoscientific, Inc. devices

FDA 510(k) Submission Details - K160016

510(k) Number K160016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2016
Decision Date July 15, 2016
Days to Decision 192 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 125d · This submission: 192d
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 61
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K160016.
Electronic Stethoscope DS3011A
K173663 · Imediplus, Inc. · Aug 2018
CliniCloud Stethoscope
K173448 · Stethocloud Pty.Ltd (Clinicloud) · Jan 2018
Adscope 658 Electronic Stethoscope
K162589 · American Diagnostic Corp. · Mar 2017
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
K083903 · 3M Company · Jul 2009
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
K060321 · American Diagnostic Corp. · May 2006
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100
K051790 · 3M Company · Jul 2005