Panmed, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Panmed, Inc.” (first 1978, latest 1986), across 15 product codes in 2 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | 2 | 2 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| GHM | Test, Sickle Cell | 1 | 1 |
Plus 5 more product codes.
Review panels
- Clinical Chemistry (15)
- Hematology (1)
Most recent Panmed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852767 | ERYTHOCYTE CREATINE | JLA | 1986-11-13 | 503 |
| K820642 | SICKLE-CHECK | GHM | 1982-04-14 | 37 |
| K802164 | 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. | CIC | 1980-10-10 | 32 |
| K802163 | CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT | CHJ | 1980-10-10 | 32 |
| K802162 | CO2 COLOR REAGENT & CO2 SAMPLE DILUENT | KMS | 1980-10-10 | 32 |
| K802161 | BIURET REAGENT & TOTAL PROTEIN BLANK SOL | CEK | 1980-10-10 | 32 |
| K802160 | BUN COLOR REAGENT & BUN ACID USED | CDW | 1980-10-10 | 32 |
| K802159 | AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS | CEO | 1980-10-10 | 32 |
| K802158 | POSTASSIUM BUFFER SOL. & WASH SOLUTION | CEM | 1980-10-10 | 32 |
| K802157 | BCG REAGENT SERUM ALBUMIN W/TECHNICON | CIX | 1980-10-10 | 32 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Panmed, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Panmed, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Panmed, Inc.” (first 1978, latest 1986), across 15 product codes in 2 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 Panmed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Panmed, Inc. is 32 days.
Which FDA product codes appear under Panmed, Inc.?
The most frequent FDA product codes under this applicant name are CEK (Biuret (Colorimetric), Total Protein, 2); CDW (Diacetyl-Monoxime, Urea Nitrogen, 1); CEM (Electrode, Ion Specific, Potassium, 1).
Next steps
- See all 16 Panmed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEK, Panmed, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.