FDA product code PZR: Percutaneous Nerve Stimulator For Opioid Withdrawal
PZR is the FDA product code for percutaneous nerve stimulator for opioid withdrawal. It is a Class II device, regulated under 21 CFR 882.5896 and reviewed by the Neurology panel. FDA has cleared 7 510(k) submissions under PZR, 4 in the last five years, from 3 different applicants. The average 510(k) review took 135 days (median 133); 185 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for PZR devices, 1 initiated in the last five years.
Definition
Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.
Classification
| Field | Value |
|---|---|
| Device name | Percutaneous Nerve Stimulator For Opioid Withdrawal |
| Device class | Class II |
| Regulation | 21 CFR 882.5896 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for PZR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 133 |
| 2021 | 2 | 156 |
| 2022 | 1 | 38 |
| 2023 | 1 | 90 |
| 2024 | 1 | 245 |
| 2025 | 1 | 125 |
Compare with all 510(k) review times · Search every PZR clearance
Top PZR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spark Biomedical, Inc. | 3 | 2025-08-25 |
| Dyansys, Inc. | 3 | 2022-06-06 |
| Net Recovery | 1 | 2024-05-29 |
Most recent PZR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251246 | Spark Biomedical, Inc. | Sparrow Ascent | 2025-08-25 | 125 |
| K233166 | Net Recovery | NET Recovery Corp/NET Device | 2024-05-29 | 245 |
| K230796 | Spark Biomedical, Inc. | Sparrow Ascent | 2023-06-20 | 90 |
| K221231 | Dyansys, Inc. | Drug Relief v1 | 2022-06-06 | 38 |
| K211971 | Dyansys, Inc. | Drug Relief v1 | 2021-11-05 | 134 |
Recalls for PZR devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-07-02.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code PZR?
PZR is the FDA product code for percutaneous nerve stimulator for opioid withdrawal. It is a Class II device, regulated under 21 CFR 882.5896 and reviewed by the Neurology panel.
What device class is PZR?
Class II, regulation 21 CFR 882.5896. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZR?
Across 7 cleared submissions the average was 135 days from receipt to decision (median 133).
Which companies have the most PZR clearances?
Spark Biomedical, Inc. (3); Dyansys, Inc. (3); Net Recovery (1).
Have PZR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-07-02.
Next steps
- Run an FDA pathway report with predicate devices for product code PZR
- Run a recall and safety report across every PZR manufacturer
- Watch product code PZR 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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