Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medica Corporation — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
484 daysmedian FDA review time
903 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220328 | EasyStat 300 | Medica Corporation | 2024-07-26 | 903 | 0 |
| K220396 | EasyStat 300 | Medica Corporation | 2023-09-26 | 592 | 0 |
| K211559 | EasyStat 300 | Medica Corporation | 2023-01-27 | 617 | 0 |
| K152327 | EasyLyte Na/K/Cl/Ca Analyzer | Medica Corporation | 2016-12-01 | 471 | 0 |
| K130080 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIB | Medica Corporation | 2014-05-13 | 484 | 0 |
| K123586 | EASYRA CREATININE REAGENT | Medica Corporation | 2013-05-15 | 175 | 0 |
| K111036 | EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; | Medica Corporation | 2011-07-12 | 89 | 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