Cleared Traditional

K150782 - AbStats Gateway

K150782 is an FDA 510(k) clearance for AbStats Gateway, manufactured by Gi Logic, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K150782 · Gi Logic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
264d
Days
Class 2
Risk

K150782 is an FDA 510(k) clearance for the AbStats Gateway. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Gi Logic, Inc. (Pasadena, US). The FDA issued a Cleared decision on December 14, 2015 after a review of 264 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 Gi Logic, Inc. devices

FDA 510(k) Submission Details - K150782

510(k) Number K150782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2015
Decision Date December 14, 2015
Days to Decision 264 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
139d slower than avg
Panel avg: 125d · This submission: 264d
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 K150782.
Electronic Stethoscope DS3011A
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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