Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alamar — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
40 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911392 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN | Alamar | 1991-05-08 | 40 | 0 |
| K911391 | ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME) | Alamar | 1991-05-08 | 40 | 0 |
| K911390 | ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM) | Alamar | 1991-05-08 | 40 | 0 |
| K911389 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM) | Alamar | 1991-05-08 | 40 | 0 |
| K910484 | ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL | Alamar | 1991-03-11 | 33 | 0 |
| K910345 | ANTIMICROBIAL CEFOPERAZONE | Alamar | 1991-02-25 | 28 | 0 |
| K910346 | ANTIMICROBIAL CEFTRIAXONE | Alamar | 1991-02-25 | 28 | 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