# K201873: Sparrow Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Spark Biomedical, Inc.
- Decided: Jan 2, 2021 after 179 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: 1 generation back to DEN170018 (2017). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170018: NSS-2 System, Innovative Health Solutions (Ihs), Inc. (2017) Summary page 4.

## Most influential descendants
- K230796: Sparrow Ascent (2023), 1 descendant of its own
- K251246: Sparrow Ascent (2025), 0 descendants of its own
- K233166: NET Recovery Corp/NET Device (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K201873
Methodology: https://510kreport.com/methodology