# K202660: SPRINT PNS System

- Pathway: 510(k) (Traditional)
- Applicant: Spr Therapeutics, Inc.
- Decided: Jan 22, 2021 after 130 days
- Product code: NHI (Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K881114 (1988). 23 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181422: SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit, Spr Therapeutics, Inc. (2018) Summary page 4.

## Most influential descendants
- K213188: Primary Relief (2022), 1 descendant of its own
- K211801: SPRINT PNS System (2021), 1 descendant of its own
- K223306: SPRINT Peripheral Nerve Stimulation (PNS) System (2023), 0 descendants of its own
- K221425: Primary Relief (2022), 0 descendants of its own
- K212859: First Relief (2021), 0 descendants of its own

## Indications for use
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days in the back and/or extremities for: * Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; * Symptomatic relief of post-traumatic pain; * Symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to treat pain in the craniofacial region.

Source page: https://510kreport.com/device/K202660
Methodology: https://510kreport.com/methodology