Spr Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Spr Therapeutics, Inc.” (first 2016, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 108 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 89 |
| 2017 | 1 | 90 |
| 2018 | 1 | 61 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 128 |
| 2022 | 0 | — |
| 2023 | 1 | 90 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 734 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spr Therapeutics, Inc. took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | 6 | 6 |
| SCN | Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief | 1 | 1 |
Review panels
- Neurology (7)
Most recent Spr Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240974 | SPRINT PNS System | SCN | 2026-04-14 | 734 |
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | NHI | 2023-01-25 | 90 |
| K211801 | SPRINT PNS System | NHI | 2021-10-13 | 125 |
| K202660 | SPRINT PNS System | NHI | 2021-01-22 | 130 |
| K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit | NHI | 2018-07-31 | 61 |
| K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit | NHI | 2017-06-26 | 90 |
| K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs | NHI | 2016-07-23 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Spr Therapeutics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Spr Therapeutics, Inc. is the lead sponsor of 9 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05491915: The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain (Active not recruiting, started 2022-10-24)
- NCT04341948: Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System (Completed, started 2020-08-06)
- NCT04246281: The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain (Active not recruiting, started 2020-06-17)
- NCT03286543: Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System (Completed, started 2017-09-05)
- NCT03179202: Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS) (Completed, started 2017-06-23)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spr Therapeutics, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Spr Therapeutics, Inc.” (first 2016, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spr Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spr Therapeutics, Inc. is 90 days. Since 2017: 108 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spr Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are NHI (Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief, 6); SCN (Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief, 1).
Next steps
- See all 7 Spr Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NHI, Spr Therapeutics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.