Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Accumed Intl., Inc. — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

84 daysmedian FDA review time
196 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K984489SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATESAccumed Intl., Inc.1999-02-16610
K983306SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACAccumed Intl., Inc.1998-12-18880
K983310SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIAccumed Intl., Inc.1998-12-17870
K983309SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXAAccumed Intl., Inc.1998-12-14840
K983301SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACAccumed Intl., Inc.1998-11-25650
K982786TRACCELL 2000 SLIDE MAPPING SYSTEMAccumed Intl., Inc.1998-10-16670
K972576GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90Accumed Intl., Inc.1998-01-221960
K964689TRACCELL 2000 SLIDE MAPPING SYSTEMAccumed Intl., Inc.1997-08-182690
K972756MODIFICATION OF EST CULTURE SYSTEM II - MYCOAccumed Intl., Inc.1997-08-01630
K965190SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATEAccumed Intl., Inc.1997-03-19850
K960366SENSITITRE 18 HOUR SUSCEPTIBILITY PLATESAccumed Intl., Inc.1996-04-09750
K960235SENSITITRE 18 HOUR SUSCEPTIBILITY PLATESAccumed Intl., Inc.1996-03-27700

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