510(k) · Cleared
ClearedGSI Audera Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grason Stadler · GWJ Stimulator, Auditory, Evoked Response
Cleared on Apr 24, 2020 as substantially equivalent to K163326 (Intelligent Hearing Systems, 2017) and 1 other predicate after a 176-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Apr 24, 2020
- Review
- 176 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K930328 (1993). 25 ancestors in all, the oldest K890495 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
- 5 generations backK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
- 4 generations backK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
- 3 generations backK021895 Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp. · 2002
- 2 generations backK031051 Smartep-Assr, Model M811007Intelligent Hearing Systems · 2004
- 1 generation backK061443 Smart Usblite, Model M011120Intelligent Hearing Systems · 2006
- This deviceK193033 GSI Audera ProGrason Stadler · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930328 | Navigator & Traveler Evoked Postential Product | Bio-Logic Systems Corp. | 1993 | — |
| −5 | K992807 | Bio-Logic Evoked Potential for Abaer I | Bio-Logic Systems Corp. | 1999 | — |
| −4 | K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. | Bio-Logic Systems Corp. | 1999 | — |
| −3 | K021895 | Bio-Logic Master Evoked Response System | Bio-Logic Systems Corp. | 2002 | — |
| −2 | K031051 | Smartep-Assr, Model M811007 | Intelligent Hearing Systems | 2004 | — |
| −1 | K061443 | Smart Usblite, Model M011120 | Intelligent Hearing Systems | 2006 | — |
| 0 (this device) | K193033 | GSI Audera Pro | Grason Stadler | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K163326 | SmartEPSummary page 4…ssification Name: Evoked Response Auditory Stimulator (21 CFR 882.1900) Regulatory Class: Class II Product Code: GWJ III. PREDICATE DEVICE K163326, Predicate for: Hardware platform for all modules, Software platform for VEMP and AEP modules Manufacturer: Intelligent He… | 2017 |
| * | K061443 | Smart Usblite, Model M011120Summary page 4…Classification Name: Evoked Response Auditory Stimulator (21 CFR 882.1900) Regulatory Class: Class II Product Code: GWJ, GWF, GWE, ETN K061443, Predicate for: ASSR, DPOAE, and TEOAE modules Trade/Device Name: Smart USBLite (with SmartEP, SmartScreener, SmartOAE, Sm… | 2006 |
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 27 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 25 ancestors has a recall of any class.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Audera Pro is intended to be used for the stimulation, recording and measurement of auditory evoked potentials, vestibular evoked myogenic potentials, auditory steady state responses and otoacoustic emissions. The device is indicated for use in the evaluation, identification, documentation and diagnosis of auditory and vestibular disorders. The device is intended to be used on patients of any age. The Audera Pro is intended to be used by qualified…
Read the full statement (249 words)
The Audera Pro is intended to be used for the stimulation, recording and measurement of auditory evoked potentials, vestibular evoked myogenic potentials, auditory steady state responses and otoacoustic emissions. The device is indicated for use in the evaluation, identification, documentation and diagnosis of auditory and vestibular disorders. The device is intended to be used on patients of any age.
The Audera Pro is intended to be used by qualified medical personnel such as an audiologist, physician, hearing healthcare professional, or trained technician. The Audera Pro is intended to be used in a hospital, clinic, or other healthcare facility with a suitable quiet testing environment.
The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient’s ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient’s scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are the patient’s ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient’s head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for otoacoustic emission (DPOAE, TEOAE) testing are the patient’s ear canal (with the contact object being an ear probe and eartip).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193033 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193033: GSI Audera Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193033
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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