Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pfizer Pharmaceuticals — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
84 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K885321 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | Pfizer Pharmaceuticals | 1989-03-22 | 84 | 0 |
| K810427 | CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP. | Pfizer Pharmaceuticals | 1981-03-31 | 41 | 0 |
| K802408 | E-VAC BLOOD CULTURE SYSTEM | Pfizer Pharmaceuticals | 1980-10-23 | 20 | 0 |
| K771605 | CREATINE KINASE ISOENZYME SUBSTRATE SET | Pfizer Pharmaceuticals | 1977-09-15 | 24 | 0 |
| K770801 | MICROBIO. PROD. FLUORESCENT ANTIBODY | Pfizer Pharmaceuticals | 1977-05-25 | 23 | 0 |
| K770425 | NEEDLES, STERILE, AIRWAY | Pfizer Pharmaceuticals | 1977-04-15 | 39 | 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