FDA product code PDQ: Neurosurgical Nerve Locator
PDQ is the FDA product code for neurosurgical nerve locator. It is a Class II device, regulated under 21 CFR 874.1820 and reviewed by the Neurology panel. FDA has cleared 36 510(k) submissions under PDQ, 6 in the last five years, from 21 different applicants. The average 510(k) review took 175 days (median 167); 170 days on average over the last three years. FDA has posted 2 recalls for PDQ devices.
Definition
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Classification
| Field | Value |
|---|---|
| Device name | Neurosurgical Nerve Locator |
| Device class | Class II |
| Regulation | 21 CFR 874.1820 |
| Review panel | NE — Neurology |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for PDQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 120 |
| 2018 | 4 | 160 |
| 2019 | 4 | 176 |
| 2021 | 2 | 172 |
| 2022 | 2 | 82 |
| 2023 | 1 | 88 |
| 2025 | 1 | 213 |
| 2026 | 2 | 126 |
Compare with all 510(k) review times · Search every PDQ clearance
Top PDQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spineguard S.A. | 5 | 2022-03-31 |
| Nu Vasive, Incorporated | 5 | 2017-03-16 |
| Medos International SARL | 3 | 2023-02-10 |
| Alphatec Spine, Inc. | 3 | 2022-09-23 |
| Magstim Company, Ltd. | 2 | 2021-03-17 |
16 more applicants have PDQ clearances. See the full list in Caduvo.
Most recent PDQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260992 | Neuralytix | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | 2026-06-25 | 91 |
| K253580 | Tedan Surgical Innovations | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | 2026-04-26 | 160 |
| K243636 | Neuralytix, LLC | Neuralytix iD3 System (NTX-9001) | 2025-06-26 | 213 |
| K223438 | Medos International SARL | TELIGEN System Peripheral Motor Nerve Stimulation Indications | 2023-02-10 | 88 |
| K221821 | Alphatec Spine, Inc. | ATEC IOM Accessory Instruments | 2022-09-23 | 92 |
Recalls for PDQ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-06-23.
| Year | Recalls |
|---|---|
| 2020 | 2 |
Frequently asked questions
What is FDA product code PDQ?
PDQ is the FDA product code for neurosurgical nerve locator. It is a Class II device, regulated under 21 CFR 874.1820 and reviewed by the Neurology panel.
What device class is PDQ?
Class II, regulation 21 CFR 874.1820. Typical premarket route: 510(k).
How long does a 510(k) take for product code PDQ?
Across 36 cleared submissions the average was 175 days from receipt to decision (median 167).
Which companies have the most PDQ clearances?
Spineguard S.A. (5); Nu Vasive, Incorporated (5); Medos International SARL (3); Alphatec Spine, Inc. (3); Magstim Company, Ltd. (2).
Have PDQ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2020-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code PDQ
- Run a recall and safety report across every PDQ manufacturer
- Watch product code PDQ 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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