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

Exigent Diagnostics, Inc. — Predicate Candidate Screening

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

36 daysmedian FDA review time
83 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K982118CARESIDE ANALYZERExigent Diagnostics, Inc.1998-07-24510
K981899CARESIDE HDL-CHOLESTEROLExigent Diagnostics, Inc.1998-07-14430
K981183CARESIDE GLUCOSEExigent Diagnostics, Inc.1998-05-07360
K980043CARESIDE CREATININEExigent Diagnostics, Inc.1998-03-30830
K980056CARESIDE ANALYZERExigent Diagnostics, Inc.1998-03-06590
K980057CARESIDE BUNExigent Diagnostics, Inc.1998-02-05300
K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.1998-02-04290
K980041CARESIDE ALBUMINExigent Diagnostics, Inc.1998-02-04290
K980055CARESIDE GLOBULINExigent Diagnostics, Inc.1998-01-28220

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