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

Spectral Diagnostics, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time
103 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K052519SPECTRAL WEST NILE VIRUS IGM STATUS TESTSpectral Diagnostics, Inc.2006-11-304420
DEN030002ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICESpectral Diagnostics, Inc.2003-06-16630
K030057SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TESpectral Diagnostics, Inc.2003-03-19710
K022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTSpectral Diagnostics, Inc.2002-09-30680
K020950SPECTRAL'S 2 IN 1 (TNI-MYO)Spectral Diagnostics, Inc.2002-05-24600
K014105SPECTRAL'S TROPONIN ISpectral Diagnostics, Inc.2002-02-01500
K992127CARDIOQUANT TROPONIN I TESTSpectral Diagnostics, Inc.1999-10-041030
K991447CARDIOQUANT CARDIAC ASSESSMENT CONTROLSSpectral Diagnostics, Inc.1999-06-11460
K982679MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TESTSpectral Diagnostics, Inc.1998-10-07680
K981474CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)Spectral Diagnostics, Inc.1998-05-07130
K972687CARDIAC STATUS CONTROLS/TROPONIN ISpectral Diagnostics, Inc.1997-07-28110
K972408CARDIAC STATUS CONTROLSSpectral Diagnostics, Inc.1997-07-25290

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