FDA product code GWM: Device, Monitoring, Intracranial Pressure
GWM is the FDA product code for device, monitoring, intracranial pressure. It is a Class II device, regulated under 21 CFR 882.1620 and reviewed by the Neurology panel. FDA has cleared 105 510(k) submissions under GWM, 4 in the last five years, from 45 different applicants. The average 510(k) review took 149 days (median 87); 201 days on average over the last three years. FDA has posted 52 recalls for GWM devices, 12 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Monitoring, Intracranial Pressure |
| Device class | Class II |
| Regulation | 21 CFR 882.1620 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GWM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 110 |
| 2018 | 1 | 298 |
| 2019 | 2 | 237 |
| 2020 | 3 | 30 |
| 2021 | 2 | 238 |
| 2024 | 2 | 127 |
| 2025 | 1 | 210 |
| 2026 | 1 | 267 |
Compare with all 510(k) review times · Search every GWM clearance
Top GWM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 9 | 2017-11-08 |
| Innerspace, Inc. | 7 | 2012-05-02 |
| Raumedic AG | 6 | 2025-08-29 |
| Integra LifeSciences Corporation | 5 | 2014-03-06 |
| Integra Neurosciences | 5 | 2005-05-11 |
40 more applicants have GWM clearances. See the full list in Caduvo.
Most recent GWM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252241 | Sophysa | Pressio 3 Multi-parameter Neuromonitoring System | 2026-04-10 | 267 |
| K250285 | Raumedic AG | NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL | 2025-08-29 | 210 |
| K240821 | Braincare Desenvolvimento E Inovação Tecnológica S.A. | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | 2024-07-18 | 115 |
| K232890 | Integra Lifesciences Production Corporation | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | 2024-02-04 | 139 |
| K201989 | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | B4C System | 2021-10-08 | 448 |
Recalls for GWM devices
52 product recalls in 28 recall events; 12 initiated in the last five years and 13 still open. Most recent: 2025-12-12.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 6 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code GWM?
GWM is the FDA product code for device, monitoring, intracranial pressure. It is a Class II device, regulated under 21 CFR 882.1620 and reviewed by the Neurology panel.
What device class is GWM?
Class II, regulation 21 CFR 882.1620. Typical premarket route: 510(k).
How long does a 510(k) take for product code GWM?
Across 105 cleared submissions the average was 149 days from receipt to decision (median 87).
Which companies have the most GWM clearances?
Codman & Shurtleff, Inc. (9); Innerspace, Inc. (7); Raumedic AG (6); Integra LifeSciences Corporation (5); Integra Neurosciences (5).
Have GWM devices been recalled?
Yes: 52 product recalls across 28 recall events; the most recent began 2025-12-12.
Next steps
- Run an FDA pathway report with predicate devices for product code GWM
- Run a recall and safety report across every GWM manufacturer
- Watch product code GWM 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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