De Novo · Granted
GrantedNSS-2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health Solutions (Ihs), Inc. · PZR Percutaneous Nerve Stimulator For Opioid Withdrawal
Granted on Nov 15, 2017 as a new device type through De Novo after a 243-day review. 7 later devices descend from it.
- Decided
- Nov 15, 2017
- Review
- 243 days
- Class
- Class II
- Product code
- PZR
- Recalls
- None
7 later devices descend from it, 2 citing it directly.
- This deviceDEN170018 NSS-2 SystemInnovative Health Solutions (Ihs), Inc. · 2017
- Descendant · cites it directly · 3 of its ownK201873 Sparrow Therapy SystemSpark Biomedical, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK173861 Drug ReliefDyansys, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK230796 Sparrow AscentSpark Biomedical, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK211971 Drug Relief v1Dyansys, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK251246 Sparrow AscentSpark Biomedical, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K201873Sparrow Therapy SystemSpark Biomedical, Inc. · 2021 · cites it directly3descendants
- K173861Drug ReliefDyansys, Inc. · 2018 · cites it directly2descendants
- K230796Sparrow AscentSpark Biomedical, Inc. · 2023 · 2 generations on1descendant
- K211971Drug Relief v1Dyansys, Inc. · 2021 · 2 generations on1descendant
- K251246Sparrow AscentSpark Biomedical, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170018 | NSS-2 System | Innovative Health Solutions (Ihs), Inc. | 2017 | — |
| +1 | K201873 | Sparrow Therapy System | Spark Biomedical, Inc. | 2021 | — |
| +1 | K173861 | Drug Relief | Dyansys, Inc. | 2018 | — |
| +2 | K230796 | Sparrow Ascent | Spark Biomedical, Inc. | 2023 | 1 |
| +2 | K211971 | Drug Relief v1 | Dyansys, Inc. | 2021 | — |
| +3 | K251246 | Sparrow Ascent | Spark Biomedical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K201873 (Spark Biomedical, Inc., 2021) has gone furthest, with 3 descendants of its own.
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. 2017, 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 NSS-2 System is a percutaneous nerve field stimulator (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/DEN170018 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170018: NSS-2 System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170018
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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