Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Akers Biosciences, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
147 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102338 | BREATHSCN PRO | Akers Biosciences, Inc. | 2011-01-12 | 147 | 0 |
| K062971 | BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEM | Akers Biosciences, Inc. | 2006-12-18 | 80 | 0 |
| K060761 | BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS | Akers Biosciences, Inc. | 2006-04-28 | 38 | 0 |
| K052697 | HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL | Akers Biosciences, Inc. | 2006-01-04 | 98 | 0 |
| K050338 | MODIFICATION TO: INSTAREAD LITHIUM SYSTEM | Akers Biosciences, Inc. | 2005-03-04 | 21 | 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