510(k) · Cleared
Recalled · Class II · 2025Sparrow Ascent
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 Jun 20, 2023 as substantially equivalent to K201873 (Spark Biomedical, Inc., 2021) after a 90-day review. Its family tree reaches back 2 generations to 2017. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 20, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- PZR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170018 (2017). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN170018 NSS-2 SystemInnovative Health Solutions (Ihs), Inc. · 2017
- 1 generation backK201873 Sparrow Therapy SystemSpark Biomedical, Inc. · 2021
- This deviceK230796 Sparrow AscentSpark Biomedical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK251246 Sparrow AscentSpark Biomedical, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251246Sparrow AscentSpark Biomedical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170018 | NSS-2 System | Innovative Health Solutions (Ihs), Inc. | 2017 | — |
| −1 | K201873 | Sparrow Therapy System | Spark Biomedical, Inc. | 2021 | — |
| 0 (this device) | K230796 | Sparrow Ascent | Spark Biomedical, Inc. | 2023 | — |
| +1 | K251246 | Sparrow Ascent | Spark Biomedical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K201873 | Sparrow Therapy SystemSummary page 4…he Sparrow Ascent is substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K201873 Sparrow Therapy System / Spark Biomedical, Inc. The predicate device has not been subject to a desig… | 2021 |
| † | DEN170018 | NSS-2 System | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251246 | Sparrow Ascent | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2025 | Class II | Z-2287-2025 | Process control | Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K251246 (Spark Biomedical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K201873.
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. 2023, 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 Ascent 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/K230796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230796: Sparrow Ascent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230796
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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