510(k) · Cleared
ClearedSparrow Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spark Biomedical, Inc. · PZR Percutaneous Nerve Stimulator For Opioid Withdrawal
Cleared on Jan 2, 2021 as substantially equivalent to DEN170018 (Innovative Health Solutions (Ihs), Inc., 2017) after a 179-day review. Its family tree reaches back 1 generation to 2017. 3 later devices descend from it.
- Decided
- Jan 2, 2021
- Review
- 179 days
- Class
- Class II
- Product code
- PZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170018 (2017). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN170018 NSS-2 SystemInnovative Health Solutions (Ihs), Inc. · 2017
- This deviceK201873 Sparrow Therapy SystemSpark Biomedical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK230796 Sparrow AscentSpark Biomedical, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK251246 Sparrow AscentSpark Biomedical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233166 NET Recovery Corp/NET DeviceNet Recovery · 2024
Most influential descendants
Showing 3 of 3 · 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) | K201873 | Sparrow Therapy System | Spark Biomedical, Inc. | 2021 | — |
| +1 | K230796 | Sparrow Ascent | Spark Biomedical, Inc. | 2023 | 1 |
| +2 | K251246 | Sparrow Ascent | Spark Biomedical, Inc. | 2025 | — |
| +1 | K233166 | NET Recovery Corp/NET Device | Net Recovery | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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…apy System is substantially equivalent to the following predicate: Submission Predicate Device Name / Manufacturer Primary Predicate Number DEN170018 NSS-2 Bridge / Innovative Health Solutions (IHS), Inc. The predicate device has not been subject to a design r… | 2017 |
What descends from it? (3)
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?
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. 2021, 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 Sparrow is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201873 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201873: Sparrow Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201873
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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