Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mcshirley Products, Inc. · 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) |
|---|---|---|---|---|---|
| K913439 | SONIX...THERAPEUTIC SONIC MASSAGE | Mcshirley Products, Inc. | 1992-01-22 | 173 | 0 |
| K833370 | LINEAR VIBRATION A MCSHIRLEY PRODUCT | Mcshirley Products, Inc. | 1983-11-28 | 61 | 0 |
| K801982 | THE MCSHIRLEY PERCUSSOR | Mcshirley Products, Inc. | 1980-09-16 | 28 | 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