Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pfizer Hospital Products Group, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
405 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930156 | MEGA PLUS SUPER LAG SCREW | Pfizer Hospital Products Group, Inc. | 1994-02-22 | 405 | 1 |
| K915512 | DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS | Pfizer Hospital Products Group, Inc. | 1992-08-18 | 253 | 4 |
| K920831 | PCA TOTAL HIP SYSTEM (CEMENTLESS USE) | Pfizer Hospital Products Group, Inc. | 1992-06-10 | 111 | 0 |
| K920034 | DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC | Pfizer Hospital Products Group, Inc. | 1992-03-18 | 72 | 2 |
| K915184 | HOWMEDICA ALUMINA FEMORAL HEAD | Pfizer Hospital Products Group, Inc. | 1992-01-31 | 74 | 0 |
| K911656 | PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST | Pfizer Hospital Products Group, Inc. | 1991-08-13 | 123 | 0 |
| K911292 | SCHNEIDER WALLSTENT(R) | Pfizer Hospital Products Group, Inc. | 1991-05-01 | 37 | 0 |
| K905482 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE | Pfizer Hospital Products Group, Inc. | 1991-03-14 | 98 | 1 |
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