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

Primus Corp. — Predicate Candidate Screening

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

105 daysmedian FDA review time

181 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K062658	PRIMUS A1CARE ASSAY	Primus Corp.	2007-11-26	446
K013787	NYCOCARD CRP	Primus Corp.	2002-05-14	181
K014084	NYCOCARD CRP CONTROL	Primus Corp.	2002-01-07	27
K994045	PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2	Primus Corp.	1999-12-21	22
K992921	PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II	Primus Corp.	1999-11-12	74
K955283	PRIMUS VARIANT SYSTEM PVS99	Primus Corp.	1996-03-01	106
K942009	PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY	Primus Corp.	1994-09-14	142
K940008	GLYCATED PROTEIN CALIBRATORS	Primus Corp.	1994-05-09	125
K940142	GLYCATED PROTEIN CONTROLS	Primus Corp.	1994-04-26	105
K936204	GLYCATED HEMOGLOBIN CALIBRATORS	Primus Corp.	1994-03-22	83
K940143	GLYCATED HEMOGLOBIN CONTROLS	Primus Corp.	1994-03-15	63

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