FDA product code GWK: Conditioner, Signal, Physiological
GWK is the FDA product code for conditioner, signal, physiological. It is a Class II device, regulated under 21 CFR 882.1845 and reviewed by the Neurology panel. FDA has cleared 23 510(k) submissions under GWK, from 17 different applicants. The average 510(k) review took 88 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Conditioner, Signal, Physiological |
| Device class | Class II |
| Regulation | 21 CFR 882.1845 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GWK clearance
Top GWK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Respironics, Inc. | 3 | 2006-09-22 |
| Nihon Kohden America, Inc. | 2 | 1991-06-28 |
| Bio-Logic Systems Corp. | 2 | 1987-10-06 |
| Nicolet Biomedical Instruments | 2 | 1985-04-11 |
| Neurodiagnostics, Inc. | 2 | 1983-02-18 |
12 more applicants have GWK clearances. See the full list in Caduvo.
Most recent GWK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060919 | Respironics, Inc. | ACTICAL | 2006-09-22 | 171 |
| K061870 | Respironics, Inc. | VITALSENSE XHR | 2006-08-31 | 59 |
| K052489 | Respironics, Inc. | ACTIHEART | 2005-09-27 | 15 |
| K991045 | Mini-Mitter Co., Inc. | MINI-LOGGER SERIES 2000 | 1999-09-21 | 176 |
| K905594 | Nihon Kohden America, Inc. | NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 | 1991-06-28 | 197 |
Recalls for GWK devices
openFDA lists no recalls for product code GWK.
Frequently asked questions
What is FDA product code GWK?
GWK is the FDA product code for conditioner, signal, physiological. It is a Class II device, regulated under 21 CFR 882.1845 and reviewed by the Neurology panel.
What device class is GWK?
Class II, regulation 21 CFR 882.1845. Typical premarket route: 510(k).
How long does a 510(k) take for product code GWK?
Across 23 cleared submissions the average was 88 days from receipt to decision (median 68).
Which companies have the most GWK clearances?
Respironics, Inc. (3); Nihon Kohden America, Inc. (2); Bio-Logic Systems Corp. (2); Nicolet Biomedical Instruments (2); Neurodiagnostics, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GWK
- Run a recall and safety report across every GWK manufacturer
- Watch product code GWK 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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