FDA product code GWL: Amplifier, Physiological Signal
GWL is the FDA product code for amplifier, physiological signal. It is a Class II device, regulated under 21 CFR 882.1835 and reviewed by the Neurology panel. FDA has cleared 53 510(k) submissions under GWL, 8 in the last five years, from 38 different applicants. The average 510(k) review took 114 days (median 97); 110 days on average over the last three years. FDA has posted 4 recalls for GWL devices.
Classification
| Field | Value |
|---|---|
| Device name | Amplifier, Physiological Signal |
| Device class | Class II |
| Regulation | 21 CFR 882.1835 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GWL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 89 |
| 2018 | 1 | 241 |
| 2020 | 1 | 184 |
| 2021 | 2 | 190 |
| 2022 | 1 | 133 |
| 2023 | 2 | 220 |
| 2024 | 4 | 122 |
| 2025 | 1 | 97 |
Compare with all 510(k) review times · Search every GWL clearance
Top GWL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eb Neuro S.P.A. | 8 | 2024-12-12 |
| G.Tec Medical Engineering GmbH | 3 | 2017-07-05 |
| Nihon Kohden America, Inc. | 3 | 1988-09-30 |
| Neurotronics, Inc. | 2 | 2022-07-15 |
| Tms International BV | 2 | 2007-03-22 |
33 more applicants have GWL clearances. See the full list in Caduvo.
Most recent GWL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243746 | Quantalx Neroscience | Delphi Amplifier | 2025-03-12 | 97 |
| K242832 | Eb Neuro S.P.A. | NExT Station; NExT Station Advanced | 2024-12-12 | 84 |
| K240646 | Somnomed Technologies Inc., Doing Business AS Remware | DreamClear | 2024-09-04 | 181 |
| K242305 | Eb Neuro S.P.A. | BE Plus PRO, Neurotravel LIGHT | 2024-09-04 | 30 |
| K232210 | X-Trodes | X-trodes System M | 2024-02-04 | 193 |
Recalls for GWL devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-08-10.
Frequently asked questions
What is FDA product code GWL?
GWL is the FDA product code for amplifier, physiological signal. It is a Class II device, regulated under 21 CFR 882.1835 and reviewed by the Neurology panel.
What device class is GWL?
Class II, regulation 21 CFR 882.1835. Typical premarket route: 510(k).
How long does a 510(k) take for product code GWL?
Across 53 cleared submissions the average was 114 days from receipt to decision (median 97).
Which companies have the most GWL clearances?
Eb Neuro S.P.A. (8); G.Tec Medical Engineering GmbH (3); Nihon Kohden America, Inc. (3); Neurotronics, Inc. (2); Tms International BV (2).
Have GWL devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2016-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code GWL
- Run a recall and safety report across every GWL manufacturer
- Watch product code GWL 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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