Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Genmark Diagnostics, Incorporated — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
255 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) P | Genmark Diagnostics, Incorporated | 2022-04-27 | 209 | 0 |
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) P | Genmark Diagnostics, Incorporated | 2019-04-12 | 200 | 0 |
| K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BC | Genmark Diagnostics, Incorporated | 2018-12-21 | 85 | 0 |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BC | Genmark Diagnostics, Incorporated | 2018-12-20 | 178 | 0 |
| K163652 | ePlex Instrument | Genmark Diagnostics, Incorporated | 2017-06-09 | 168 | 0 |
| K163636 | ePlex Respiratory Pathogen Panel | Genmark Diagnostics, Incorporated | 2017-06-09 | 169 | 0 |
| K152612 | eSensor Warfarin Sensitivity Saliva Test | Genmark Diagnostics, Incorporated | 2016-05-26 | 255 | 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