Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Pfizer, Inc. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
161 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181102 | ThermaCare Quick Therapy TENS | Pfizer, Inc. | 2018-09-15 | 142 | 0 |
| K991620 | VISINE FOR CONTACTS | Pfizer, Inc. | 1999-09-24 | 136 | 0 |
| K892264 | ORALCHEK SUPER-SOFT BRUSH | Pfizer, Inc. | 1989-06-14 | 70 | 0 |
| K892360 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | Pfizer, Inc. | 1989-06-05 | 60 | 0 |
| K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE | Pfizer, Inc. | 1988-06-17 | 77 | 0 |
| K854726 | MEDI-WIPES UNITED ANTISEPTIC SKIN PREP | Pfizer, Inc. | 1986-02-24 | 91 | 0 |
| K850413 | MEC HIP BOLT | Pfizer, Inc. | 1985-07-15 | 161 | 0 |
| K850443 | MEC ROD CONNECTOR | Pfizer, Inc. | 1985-07-15 | 160 | 0 |
| K850840 | HOWMEDICA THREADED ACETABULAR COMPONENT | Pfizer, Inc. | 1985-07-15 | 136 | 0 |
| K850403 | MEC DISTAL FEMORAL BOLT | Pfizer, Inc. | 1985-07-15 | 164 | 0 |
| K851971 | SERIES 7000/HOLTER RECORDER | Pfizer, Inc. | 1985-06-20 | 44 | 0 |
| K852041 | DEKNATEL THORACIC CATHETER | Pfizer, Inc. | 1985-06-17 | 39 | 0 |
| K851024 | PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE | Pfizer, Inc. | 1985-05-23 | 72 | 0 |
| K850442 | MEC BROAD BONE PLATE | Pfizer, Inc. | 1985-04-19 | 73 | 0 |
| K850444 | MEC BUTRESS PLATE | Pfizer, Inc. | 1985-04-19 | 73 | 0 |
| K850401 | LETOURNEL ACETABULAR PLATE | Pfizer, Inc. | 1985-04-19 | 77 | 0 |
| K850886 | COMPRESSION HIP SCREW SYSTEM | Pfizer, Inc. | 1985-04-19 | 46 | 1 |
| K850441 | MEC INTRAMEDULLARY ROD | Pfizer, Inc. | 1985-04-19 | 73 | 0 |
| K844938 | UNITED SKIN BARRIERS | Pfizer, Inc. | 1985-01-18 | 29 | 0 |
| K792349 | SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. | Pfizer, Inc. | 1980-03-12 | 114 | 0 |
| K791523 | VISALENS ALL PURPOSE SOLUTION FOR LENS | Pfizer, Inc. | 1980-02-19 | 193 | 0 |
| K791524 | VISALENS CONCENTRATED CLEANER CONT LENS | Pfizer, Inc. | 1979-11-20 | 102 | 0 |
| K791163 | PFIZER 0200FS LOCALLZER | Pfizer, Inc. | 1979-08-03 | 39 | 0 |
| K791153 | ACTA-SCANNER 0220FS | Pfizer, Inc. | 1979-08-03 | 45 | 0 |
| K790089 | TAPE MEASURE | Pfizer, Inc. | 1979-03-06 | 48 | 0 |
| K782086 | AM-PEN SCREEN | Pfizer, Inc. | 1979-02-01 | 49 | 0 |
| K780413 | LOW IIONIC STRENGTH SOLUTION | Pfizer, Inc. | 1978-04-24 | 40 | 0 |
| K772291 | DIAG. CONSOLE, INDEPENDENT | Pfizer, Inc. | 1977-12-21 | 9 | 0 |
| K771620 | ALKALINE PHOSPHATASE ISOENZY. SUB. SET | Pfizer, Inc. | 1977-09-15 | 21 | 0 |
| K770833 | FLUORETEC-M | Pfizer, Inc. | 1977-06-08 | 33 | 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