Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Prime Pacific Health Innovations Corporation · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050112 | PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 | Prime Pacific Health Innovations Corporation | 2005-03-15 | 56 | 0 |
| K000031 | AQUANET, MODEL EC 2000 | Prime Pacific Health Innovations Corporation | 2001-09-10 | 614 | 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