Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Splintek, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
161 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250122 | SleepRight Snore Aid | Splintek, Inc. | 2025-05-19 | 122 | 0 |
| K212767 | SleepRight Select-Comfort Dental Guard | Splintek, Inc. | 2021-12-22 | 113 | 0 |
| K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Cus | Splintek, Inc. | 2021-12-13 | 109 | 0 |
| K193577 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2020-06-01 | 161 | 0 |
| K172223 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2017-11-17 | 116 | 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