Atlas FDA

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

GIL — Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

244 daysmedian FDA review time
529 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K962407N/T PROTEIN CONTROL PYBehring Diagnostics, Inc.1996-07-29380
K946265FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3Clinical Controls, Inc.1995-08-242440
K946193FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3More Diagnostics1995-08-242470
K935598PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2Clinical Controls, Inc.1995-05-025290
K951012N/T PROTEIN CONTROL PYBehring Diagnostics, Inc.1995-04-17420
K934741LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2Clinical Controls, Inc.1994-09-083420
K915462FIBRINOGEN CONTROLSigma Diagnostics, Inc.1992-03-04910
K833352GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROLWarner-Lambert Co.1983-11-03360

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