Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spr Therapeutics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
734 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240974 | SPRINT PNS System | Spr Therapeutics, Inc. | 2026-04-14 | 734 | 0 |
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | Spr Therapeutics, Inc. | 2023-01-25 | 90 | 0 |
| K211801 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021-10-13 | 125 | 0 |
| K202660 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021-01-22 | 130 | 0 |
| K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT | Spr Therapeutics, Inc. | 2018-07-31 | 61 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda