Cleared Traditional

K220139 - QScreen

K220139 is an FDA 510(k) clearance for QScreen, manufactured by Path Medical GmbH. The device is a Class 2 Ear, Nose, Throat device with product code GWJ cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K220139 · Path Medical GmbH · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
197d
Days
Class 2
Risk

K220139 is an FDA 510(k) clearance for the QScreen. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Path Medical GmbH (Germering, DE). The FDA issued a Cleared decision on August 3, 2022 after a review of 197 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 882.1900 - the FDA ear, nose and throat device 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Path Medical GmbH devices

FDA 510(k) Submission Details - K220139

510(k) Number K220139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2022
Decision Date August 03, 2022
Days to Decision 197 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 89d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - GWJ Stimulator, Auditory, Evoked Response

All 21
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K220139.
Integrity V500 (Integrity, Integrity with VEMP)
K242954 · Vivosonic, Inc. · Dec 2024
ALGO Pro Newborn Hearing Screener (ALGO Pro)
K233649 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Mar 2024
ALGO 7i
K211147 · Path Medical GmbH · Oct 2021
GSI Audera Pro
K193033 · Grason Stadler · Apr 2020
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K073626 · Bio-Logic Systems Corp. · Feb 2008
STACKED ABR FOR NAVIGATOR PRO
K030907 · Bio-Logic Systems Corp. · May 2003