FDA product code GYB: Media, Electroconductive
GYB is the FDA product code for media, electroconductive. It is a Class II device, regulated under 21 CFR 882.1275 and reviewed by the Neurology panel. FDA has cleared 69 510(k) submissions under GYB, 5 in the last five years, from 43 different applicants. The average 510(k) review took 151 days (median 100); 124 days on average over the last three years. FDA has posted 10 recalls for GYB devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Media, Electroconductive |
| Device class | Class II |
| Regulation | 21 CFR 882.1275 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GYB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 231 |
| 2019 | 1 | 190 |
| 2020 | 3 | 199 |
| 2021 | 2 | 98 |
| 2022 | 3 | 172 |
| 2023 | 1 | 550 |
| 2025 | 1 | 124 |
Compare with all 510(k) review times · Search every GYB clearance
Top GYB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vanaray Laboratories, Inc. | 7 | 1981-01-08 |
| Chester Labs, Inc. | 5 | 2000-06-29 |
| Graphic Controls Corp. | 5 | 1996-07-09 |
| Parker Laboratories, Inc. | 4 | 1985-08-09 |
| Spes Medica Srl | 3 | 2021-12-01 |
38 more applicants have GYB clearances. See the full list in Caduvo.
Most recent GYB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243749 | Shenzhen Ulike Smart Electronics Co., Ltd. | Jmoon Conductive Gel | 2025-04-08 | 124 |
| K220735 | Premier North America, Inc. | Avologi Gel Primer (Model: Av25) | 2023-09-15 | 550 |
| K222770 | Top-Rank Health Care Co., Ltd. | Conductive Gel | 2022-12-13 | 90 |
| K221724 | Tone-A-Matic International, Inc. | Conductive Gel | 2022-09-23 | 101 |
| K212325 | Somnomedics GmbH | EEG-acp | 2022-06-15 | 324 |
Recalls for GYB devices
10 product recalls in 5 recall events; 4 initiated in the last five years and 5 still open. Most recent: 2024-03-22.
| Year | Recalls |
|---|---|
| 2019 | 5 |
| 2021 | 1 |
| 2024 | 4 |
Frequently asked questions
What is FDA product code GYB?
GYB is the FDA product code for media, electroconductive. It is a Class II device, regulated under 21 CFR 882.1275 and reviewed by the Neurology panel.
What device class is GYB?
Class II, regulation 21 CFR 882.1275. Typical premarket route: 510(k).
How long does a 510(k) take for product code GYB?
Across 69 cleared submissions the average was 151 days from receipt to decision (median 100).
Which companies have the most GYB clearances?
Vanaray Laboratories, Inc. (7); Chester Labs, Inc. (5); Graphic Controls Corp. (5); Parker Laboratories, Inc. (4); Spes Medica Srl (3).
Have GYB devices been recalled?
Yes: 10 product recalls across 5 recall events; the most recent began 2024-03-22.
Next steps
- Run an FDA pathway report with predicate devices for product code GYB
- Run a recall and safety report across every GYB manufacturer
- Watch product code GYB 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.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times