510(k) · Cleared
ClearedDrug Relief
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyansys, Inc. · PZR Percutaneous Nerve Stimulator For Opioid Withdrawal
Cleared on May 2, 2018 as substantially equivalent to DEN170018 (Innovative Health Solutions (Ihs), Inc., 2017) after a 133-day review. Its family tree reaches back 1 generation to 2017. 2 later devices descend from it.
- Decided
- May 2, 2018
- Review
- 133 days
- Class
- Class II
- Product code
- PZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170018 (2017). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN170018 NSS-2 SystemInnovative Health Solutions (Ihs), Inc. · 2017
- This deviceK173861 Drug ReliefDyansys, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK211971 Drug Relief v1Dyansys, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK221231 Drug Relief v1Dyansys, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170018 | NSS-2 System | Innovative Health Solutions (Ihs), Inc. | 2017 | — |
| 0 (this device) | K173861 | Drug Relief | Dyansys, Inc. | 2018 | — |
| +1 | K211971 | Drug Relief v1 | Dyansys, Inc. | 2021 | — |
| +2 | K221231 | Drug Relief v1 | Dyansys, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PZR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PZR device
- #1 K251246 Sparrow Ascentscore 10.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN170018 | NSS-2 SystemSummary page 4…g Relief Classification Name : Percutaneous nerve stimulator for substance use disorders Product Code : PZR Predicate Device: DEN Number: DEN170018 Model Name: NSS-2 BRIDGE Manufacturer: Innovative Health Solutions, Inc. Device Description: The Drug Relie… | 2017 |
| † | K170391 | ANSiStim-PP | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211971 | Drug Relief v1 | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PZR devicesPZR Percutaneous Nerve Stimulator For Opioid Withdrawal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PZR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZR
Too few PZR 510(k)s in any year since 2007 to give a median.
Recalls per year · PZR
No recall names PZR since 2007.
Adverse event reports per year · PZR
No MAUDE report names PZR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Drug Relief is a percutaneous nerve field stimulatory (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX, and X, and the occipital nerves identified by transillumination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173861: Drug Relief.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173861
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026