Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

CDS — Predicate Candidate Screening

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

68 daysmedian FDA review time

257 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K171247	epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Tes	Epocal, Inc.	2018-01-17	264
K040973	BUN REAGENT	Genchem, Inc.	2004-12-27	257
K033056	BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT	Diamond Diagnostics, Inc.	2004-01-30	123
K925550	HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806	Hichem Diagnostics	1993-04-20	168
K860543	BLOOD UREA NITROGEN (BUN) TESTCARD	Ilex Corp.	1986-04-21	67
K855091	CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS	Sen Tech Medical Corp.	1986-03-14	84
K812308	LANCER BUN RATE REAGENT KIT	Sherwood Medical Co.	1981-08-31	14
K811193	BUN RATE REAGENT	Chem-Elec, Inc.	1981-07-10	71
K800616	BUN REAGENT KIT #88108	Hi Chem, Inc.	1980-04-10	23
K800590	BUN KIT	Nobel Scientific Industries, Inc.	1980-04-04	18
K800071	BUN REAGENT KIT	Fisher Scientific Co., LLC	1980-02-05	25
K791018	FERMCOTEST R BUN RATE REAGENT TEST KIT	Fermco Biochemics, Inc.	1979-07-17	46
K771060	DIAG. CONDUCTA RATE BUN REAG. SET	J.T. Baker Chemical Co.	1977-07-21	38
K761061	BLOOD-UREA-NITROGEN (BUN) ANALYZER 2	Beckman Instruments, Inc.	1977-01-25	68
K760430	BUN-REATIVE	Boehringer Mannheim Corp.	1976-11-01	80

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