Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Professional Positioners, 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) |
|---|---|---|---|---|---|
| K943905 | PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER | Professional Positioners, Inc. | 1995-02-27 | 200 | 0 |
| K932298 | PRO'S NEO-LASTICS | Professional Positioners, Inc. | 1994-02-14 | 279 | 0 |
| K932761 | SOFT-WEAR HEADGEAR AND SAFETY MODULES | Professional Positioners, Inc. | 1993-10-07 | 121 | 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