# K251246: Sparrow Ascent

- Pathway: 510(k) (Traditional)
- Applicant: Spark Biomedical, Inc.
- Decided: Aug 25, 2025 after 125 days
- Product code: PZR (Percutaneous Nerve Stimulator For Opioid Withdrawal)
- Device class: 2
- Regulation: 21 CFR 882.5896
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN170018 (2017). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230796: Sparrow Ascent, Spark Biomedical, Inc. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K251246
Methodology: https://510kreport.com/methodology