Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pharmaceutical Innovations, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
434 daysmedian FDA review time
435 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163026 | Ultra/Phonic Scanning Gel | Pharmaceutical Innovations, Inc. | 2018-01-09 | 435 | 0 |
| K163027 | Ultra/Phonic Free Conductivity Gel | Pharmaceutical Innovations, Inc. | 2018-01-09 | 435 | 0 |
| K163023 | Other-Sonic Transmission Gel | Pharmaceutical Innovations, Inc. | 2018-01-08 | 434 | 0 |
| K163024 | Ultra/Phonic Conductivity Gel | Pharmaceutical Innovations, Inc. | 2018-01-08 | 434 | 0 |
| K961222 | EVRON GEL | Pharmaceutical Innovations, Inc. | 1996-06-26 | 90 | 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