Warner-Lambert Co.: FDA filings under this applicant name
FDA lists 50 510(k) clearances under the applicant name “Warner-Lambert Co.” (first 1979, latest 2003), plus 1 PMA decision, across 35 product codes in 12 review panels. Median 510(k) review time under this name: 40 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 8 | 8 |
| JTN | Susceptibility Test Discs, Antimicrobial | 4 | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 | 3 |
| FCR | Light Source, Photographic, Fiberoptic | 2 | 2 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 2 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| KGZ | Accessories, Catheter | 2 | 2 |
| BZS | Stethoscope Head | 1 | 1 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
Plus 25 more product codes.
Review panels
- General Hospital (13)
- General and Plastic Surgery (8)
- Hematology (7)
- Clinical Chemistry (6)
- Microbiology (6)
- Pathology (3)
- Anesthesiology (2)
- Gastroenterology and Urology (2)
- Cardiovascular (1)
- Ophthalmic (1)
- Orthopedic (1)
- Radiology (1)
Most recent Warner-Lambert Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K024160 | NEOSPORIN SCAR SOLUTION | MDA | 2003-03-17 | 90 |
| K893452 | EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM | IZZ | 1989-06-22 | 50 |
| K870584 | O.P.T.(TM) OVULATION PREDICTION TEST | CEP | 1987-11-25 | 287 |
| K861510 | MULTILUMEN VIAPIC CENTRAL LINE CATHETER | FOZ | 1986-06-09 | 47 |
| K852967 | GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK | JTN | 1985-08-19 | 35 |
| K852689 | GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK | JTN | 1985-08-19 | 55 |
| K852843 | GENERAL DIAGNOSTICS COAG-A-MATE XC | KQC | 1985-08-13 | 39 |
| K852889 | GENERAL DIAGNOSTICS RAPID E. COLI TEST | JTO | 1985-07-23 | 14 |
| K850486 | GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY | KFF | 1985-05-08 | 90 |
| K850412 | GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY | JBQ | 1985-05-08 | 93 |
40 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P810024 | PMA | AUTOBAC MTS PLUS TEST SYTEM | 1982-03-04 |
Recalls
openFDA lists no recalls under a recalling firm named Warner-Lambert Co..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Warner-Lambert Co. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Warner/Chilcott (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Warner-Lambert Co.?
FDA lists 50 510(k) clearances under the applicant name “Warner-Lambert Co.” (first 1979, latest 2003), plus 1 PMA decision, across 35 product codes in 12 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Warner-Lambert Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Warner-Lambert Co. is 40 days.
Which FDA product codes appear under Warner-Lambert Co.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 8); JTN (Susceptibility Test Discs, Antimicrobial, 4); JJY (Multi-Analyte Controls, All Kinds (Assayed), 3).
Next steps
- See all 50 Warner-Lambert Co. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Warner-Lambert Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.