FDA product code GYD: Transducer, Tremor
GYD is the FDA product code for transducer, tremor. It is a Class II device, regulated under 21 CFR 882.1950 and reviewed by the Neurology panel. FDA has cleared 12 510(k) submissions under GYD, 5 in the last five years, from 10 different applicants. The average 510(k) review took 158 days (median 144); 94 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Tremor |
| Device class | Class II |
| Regulation | 21 CFR 882.1950 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GYD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 3 | 241 |
| 2023 | 1 | 269 |
| 2025 | 1 | 94 |
Top GYD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gkc Manufacturing Pty, Ltd. | 3 | 2022-03-11 |
| Neuhealth Digital , Ltd. | 1 | 2025-04-25 |
| New Touch Digital, Inc. | 1 | 2023-03-17 |
| H2o Bilisim Yazilim | 1 | 2022-11-17 |
| Rune Labs, Inc. | 1 | 2022-06-10 |
5 more applicants have GYD clearances. See the full list in Caduvo.
Most recent GYD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250153 | Neuhealth Digital , Ltd. | Neu Platform | 2025-04-25 | 94 |
| K221772 | New Touch Digital, Inc. | NeuroRPM | 2023-03-17 | 269 |
| K220820 | H2o Bilisim Yazilim | Parky App | 2022-11-17 | 241 |
| K213519 | Rune Labs, Inc. | Rune Labs Tremor Transducer System | 2022-06-10 | 219 |
| K211887 | Gkc Manufacturing Pty, Ltd. | Personal Kinetigraph (PKG) System Gen 2 Plus | 2022-03-11 | 263 |
Recalls for GYD devices
openFDA lists no recalls for product code GYD.
Frequently asked questions
What is FDA product code GYD?
GYD is the FDA product code for transducer, tremor. It is a Class II device, regulated under 21 CFR 882.1950 and reviewed by the Neurology panel.
What device class is GYD?
Class II, regulation 21 CFR 882.1950. Typical premarket route: 510(k).
How long does a 510(k) take for product code GYD?
Across 12 cleared submissions the average was 158 days from receipt to decision (median 144).
Which companies have the most GYD clearances?
Gkc Manufacturing Pty, Ltd. (3); Neuhealth Digital , Ltd. (1); New Touch Digital, Inc. (1); H2o Bilisim Yazilim (1); Rune Labs, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GYD
- Run a recall and safety report across every GYD manufacturer
- Watch product code GYD 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.