Medica Corp.: FDA filings under this applicant name
FDA lists 55 510(k) clearances under the applicant name “Medica Corp.” (first 1979, latest 2024), across 32 product codes in 4 review panels. Median 510(k) review time under this name: 91 days. Since 2017 the median was 617 days, against 239 days for all cleared 510(k)s in the same product codes. 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 | 1 | 83 |
| 2013 | 2 | 128 |
| 2014 | 1 | 484 |
| 2015 | 0 | — |
| 2016 | 1 | 471 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 604 |
| 2024 | 1 | 903 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medica Corp. took a median 617 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 239 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | 9 | 9 |
| CEM | Electrode, Ion Specific, Potassium | 4 | 4 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 4 | 4 |
| CGA | Glucose Oxidase, Glucose | 3 | 3 |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 3 |
| JFP | Electrode, Ion Specific, Calcium | 3 | 3 |
| CGZ | Electrode, Ion-Specific, Chloride | 2 | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 2 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
Plus 22 more product codes.
Review panels
- Clinical Chemistry (43)
- Immunology (8)
- Hematology (2)
- Clinical Toxicology (2)
Most recent Medica Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220328 | EasyStat 300 | CGA | 2024-07-26 | 903 |
| K220396 | EasyStat 300 | CEM | 2023-09-26 | 592 |
| K211559 | EasyStat 300 | CHL | 2023-01-27 | 617 |
| K152327 | EasyLyte Na/K/Cl/Ca Analyzer | JFP | 2016-12-01 | 471 |
| K130080 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL | JHY | 2014-05-13 | 484 |
| K123586 | EASYRA CREATININE REAGENT | CGX | 2013-05-15 | 175 |
| K123802 | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT | CIG | 2013-03-01 | 81 |
| K120497 | EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL | LCP | 2012-05-14 | 83 |
| K111363 | PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL | JXN | 2011-12-06 | 204 |
| K111005 | ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL | DIC | 2011-11-15 | 218 |
45 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 5 recall events; 1 initiated in the last five years. Most recent: 2025-12-31.
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.
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.
- Medica Holdings, LLC (3 510(k)s)
- Medica Health, Ltd. (1 510(k)s)
- Medica S.R.L. (1 510(k)s)
- Medica USA, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medica Corp.?
FDA lists 55 510(k) clearances under the applicant name “Medica Corp.” (first 1979, latest 2024), across 32 product codes in 4 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 Medica Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medica Corp. is 91 days. Since 2017: 617 days, versus 239 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medica Corp.?
The most frequent FDA product codes under this applicant name are JGS (Electrode, Ion Specific, Sodium, 9); CEM (Electrode, Ion Specific, Potassium, 4); CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 4).
Next steps
- See all 55 Medica Corp. clearances with predicates and recalls
- Run predicate analysis for product code JGS, Medica Corp.'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.