510(k) · Cleared
ClearedQScreen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Path Medical GmbH · GWJ Stimulator, Auditory, Evoked Response
Cleared on Aug 3, 2022 as substantially equivalent to K133012 (Path Medical GmbH, 2014) after a 197-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Aug 3, 2022
- Review
- 197 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K902540 (1990). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- 5 generations backK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- 4 generations backK982642 Echo-ScreenFischer-Zoth Audiologic Systems, Inc. · 1998
- 3 generations backK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- 2 generations backK061744 Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006
- 1 generation backK133012 SentieroPath Medical GmbH · 2014 · Recalled
- This deviceK220139 QScreenPath Medical GmbH · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| −5 | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| −4 | K982642 | Echo-Screen | Fischer-Zoth Audiologic Systems, Inc. | 1998 | — |
| −3 | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| −2 | K061744 | Cochlea-Scan / Cochlea-Scan Plus | Bio-Logic Systems Corp. | 2006 | — |
| −1 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| 0 (this device) | K220139 | QScreen | Path Medical GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWJ device
- #1 K242954 Integrity V500 (Integrity, Integrity with VEMP)score 10.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133012 | SentieroSummary page 4…Stimulator FDA 21CFR882.1900 & 21CFR874.1050 PREDICATE DEVICE Sentiero 510(k) Number: K133012 DEVICE DESCRIPTION The QScreen is a hand-held and portable audiometric examination device offering test methods for the measur… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- 4 of the 26 ancestors have a recall of any class.
- 2 other devices also cite its predicate K133012.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWJ
111in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWJ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWJ
1in 2025
MAUDE reports naming product code GWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 4 | 64 | 1 | 0 |
| 2009 | 4 | 111 | 0 | 0 |
| 2010 | 1 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 43 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 0 | — | 1 | 5 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 2 | — | 0 | 7 |
| 2025 | 0 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The QSCREEN device is a hand-held, portable hearing screener intended for recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR). Distortion Product Otoacoustic Emission (DPOAE) and Transient Evoked Otoacoustic Emission (TEOAE) tests are applicable to obtain objective evidence of peripheral auditory function. ABR tests are applicable to obtain objective evidence of peripheral and retro-cochlear auditory function including the auditory nerve and the brainstem. QSCREEN is intended to be used in subjects of all ages. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220139: QScreen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220139
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026