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

Awareness Technology, Inc. — Predicate Candidate Screening

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

69 daysmedian FDA review time
277 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc.2018-02-272840
K013420CHEMWELL, ALSO KNOWN AS PROJECT 2900Awareness Technology, Inc.2002-07-192770
K010877CHEMWELL, MODEL 2900Awareness Technology, Inc.2001-05-23610
K974762STAT TRACKSAwareness Technology, Inc.1998-01-28400
K943729DYE CHECK STRIPS 545-630Awareness Technology, Inc.1994-12-291490
K941394STAT FAX 2600Awareness Technology, Inc.1994-06-03730
K923598REDI-CHECK PHOTMETER Q.A.Awareness Technology, Inc.1992-10-14860
K900224STAT FAX(TM)-2100Awareness Technology, Inc.1990-03-01430
K892656DRI-DYE CHECK STRIPS (TM)-405Awareness Technology, Inc.1989-05-22390
K882938STAT FAX(TM)Awareness Technology, Inc.1988-09-09580
K873451PROJECT 300 MICROASSAY BP-12, EIA MINILABAwareness Technology, Inc.1987-11-04690
K871679FOCUS-GHBAwareness Technology, Inc.1987-07-28900
K864634AP1 COLORIMETERAwareness Technology, Inc.1986-12-31360
K861697SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)Awareness Technology, Inc.1986-08-191060
K851467HEMOGLOBIN ANALYZERAwareness Technology, Inc.1985-07-16920
K850994SPECTRA 1 FILTER PHOTOMETERAwareness Technology, Inc.1985-05-10600
K850995SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER PAwareness Technology, Inc.1985-05-10600
K850993SMART ALEX II MULTI-FILTER PHOTOMETERAwareness Technology, Inc.1985-05-07570

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