510(k) · Cleared
ClearedHearlab Aca
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Frye Electronics, Inc. · GWJ Stimulator, Auditory, Evoked Response
Cleared on Apr 5, 2013 after a 123-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 5, 2013
- Review
- 123 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 HEARLab device is intended for use in evoking an auditory response and recording, analyzing, and displaying the resulting human electro-physiological data as an aid for hearing assessment used in conjunction with other clinical devices (such as an audiometer or an auditory brainstemt response device). Healthcare professionals trained in auditory evoked potentials can use HEARLab in order to determine whether the Cortical Auditory Evoked Potential…
Read the full statement (157 words)
The HEARLab device is intended for use in evoking an auditory response and recording, analyzing, and displaying the resulting human electro-physiological data as an aid for hearing assessment used in conjunction with other clinical devices (such as an audiometer or an auditory brainstemt response device).
Healthcare professionals trained in auditory evoked potentials can use HEARLab in order to determine whether the Cortical Auditory Evoked Potential (CAEP) is absent or present in humans from infants who are 42 weeks gestational through adults when stimulated with speech tokens presented in the sound field. This test can be performed on unaided subjects and subjects wearing hearing instruments. However, it is not meant to be used on subjects with cochlear implants.
These professionals can also use HEARLab to determine audibility of unaided firequency-specific tones presented to adults using CAEP. Only audiologists should use information acquired by HEAR~ab in diagnosing a hearing loss or in verifying the effectiveness of a hearing aid.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123701 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123701: Hearlab Aca.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123701
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026