FDA product code GWJ: Stimulator, Auditory, Evoked Response
GWJ is the FDA product code for stimulator, auditory, evoked response. It is a Class II device, regulated under 21 CFR 882.1900 and reviewed by the Neurology panel. FDA has cleared 76 510(k) submissions under GWJ, 3 in the last five years, from 40 different applicants. The average 510(k) review took 114 days (median 86); 100 days on average over the last three years. FDA has posted 4 recalls for GWJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Auditory, Evoked Response |
| Device class | Class II |
| Regulation | 21 CFR 882.1900 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GWJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 274 |
| 2020 | 1 | 176 |
| 2021 | 1 | 178 |
| 2022 | 1 | 197 |
| 2024 | 2 | 100 |
Compare with all 510(k) review times · Search every GWJ clearance
Top GWJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intelligent Hearing Systems | 8 | 2017-09-29 |
| Bio-Logic Systems Corp. | 7 | 2008-02-05 |
| Path Medical GmbH | 4 | 2022-08-03 |
| Natus Medical, Inc. | 4 | 2008-01-25 |
| Vivosonic, Inc. | 3 | 2024-12-19 |
35 more applicants have GWJ clearances. See the full list in Caduvo.
Most recent GWJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242954 | Vivosonic, Inc. | Integrity V500 (Integrity, Integrity with VEMP) | 2024-12-19 | 85 |
| K233649 | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | ALGO Pro Newborn Hearing Screener (ALGO Pro) | 2024-03-08 | 115 |
| K220139 | Path Medical GmbH | QScreen | 2022-08-03 | 197 |
| K211147 | Path Medical GmbH | ALGO 7i | 2021-10-14 | 178 |
| K193033 | Grason Stadler | GSI Audera Pro | 2020-04-24 | 176 |
Recalls for GWJ devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-06.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code GWJ?
GWJ is the FDA product code for stimulator, auditory, evoked response. It is a Class II device, regulated under 21 CFR 882.1900 and reviewed by the Neurology panel.
What device class is GWJ?
Class II, regulation 21 CFR 882.1900. Typical premarket route: 510(k).
How long does a 510(k) take for product code GWJ?
Across 76 cleared submissions the average was 114 days from receipt to decision (median 86).
Which companies have the most GWJ clearances?
Intelligent Hearing Systems (8); Bio-Logic Systems Corp. (7); Path Medical GmbH (4); Natus Medical, Inc. (4); Vivosonic, Inc. (3).
Have GWJ devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2025-11-06.
Next steps
- Run an FDA pathway report with predicate devices for product code GWJ
- Run a recall and safety report across every GWJ manufacturer
- Watch product code GWJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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