Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sprintray, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
163 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260661 | Midas Restore | Sprintray, Inc. | 2026-04-15 | 44 | 0 |
| K250617 | Apex Flex | Sprintray, Inc. | 2025-04-29 | 60 | 0 |
| K242559 | Digital Temp | Sprintray, Inc. | 2024-11-26 | 90 | 0 |
| K242277 | Crown HT | Sprintray, Inc. | 2024-10-01 | 61 | 0 |
| K230445 | OnX Tough | Sprintray, Inc. | 2023-07-14 | 143 | 0 |
| K222623 | Digital Crown | Sprintray, Inc. | 2022-12-14 | 105 | 0 |
| K221678 | SprintRay High Impact Denture Base | Sprintray, Inc. | 2022-11-10 | 154 | 0 |
| K220979 | SprintRay Denture Base | Sprintray, Inc. | 2022-09-14 | 163 | 0 |
| K212448 | NightGuard Flex | Sprintray, Inc. | 2021-11-12 | 99 | 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