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

CDM — Predicate Candidate Screening

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

111 daysmedian FDA review time

432 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K052719	URITEST 10 URINALYSIS REAGENT STRIPS	Arj Medical, Inc.	2006-12-05	432	0
K061559	ACON URINALYSIS REAGENT STRIPS	Acon Laboratories Co.	2006-08-11	67	1
K880584	URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C	Mach Diag. C/O Wichita State University	1988-05-31	111	0
K873366	WAKO(TM) PRETEST 5A	Wako Chemicals USA, Inc.	1988-01-21	153	0
K852611	TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE	Miles Laboratories, Inc.	1985-09-03	76	0
K821799	FITKIT I CHECKUP KIT	Patton, Boggs & Blow	1983-08-16	424	0
K830340	FITKIT I CHECKUP KIT	Boditestor	1983-08-16	195	0
K831623	DIA STRIPS SYSTEM	California Immuno Diagnostic, Inc.	1983-07-28	69	0
K790965	REAGENT STRIPS FOR URINALYSIS	Miles Laboratories, Inc.	1979-06-28	37	0

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