Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Power Products, Inc.-Splintek — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100545 | SLEEPRIGHT | Power Products, Inc.-Splintek | 2010-06-04 | 98 | 0 |
| K071404 | SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE | Power Products, Inc.-Splintek | 2007-08-17 | 88 | 0 |
| K022809 | EZ SPLINT & EZ SPLINT PM | Power Products, Inc.-Splintek | 2003-10-17 | 420 | 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