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

CFM — Predicate Candidate Screening

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

35 daysmedian FDA review time

69 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K984119	WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR	Wako Chemicals USA, Inc.	1999-01-15	58
K981581	IRON	Abbott Laboratories	1998-06-08	35
K932871	UIBC FOR DISCREET RANDOM ACCESS ANALYZER	Catachem, Inc.	1993-09-08	86
K913705	ABBOTT QLUICKSTART IRON TEST, ITEM #5A29	Em Diagnostic Systems, Inc.	1991-10-09	51
K912912	SYNERMED SERUM IRON-600 REAGENT KIT	Synermed, Inc.	1991-07-30	27
K902918	SYNERMED SERUM IRON REAGENT KIT	Synermed, Inc.	1990-07-31	28
K895047	CLINISTAT POTASSIUM REAGENT TEST	Heraeus Kulzer, Inc.	1989-10-17	69
K891155	IRON REAGENT	Medical Analysis Systems, Inc.	1989-04-18	43
K873120	ABBOTT A-GENT IRON REAGENT KIT	Abbott Laboratories	1987-08-25	15
K861602	TOTAL IRON BINDING CAPACITY PROCEDURE	Data Medical Associates, Inc.	1986-05-23	24
K854305	DART IRON & IRON BINDING CAPACITY REAGENT	Coulter Electronics, Inc.	1985-11-12	18
K852583	DATA CHEM IRON PROCEDURE	Data Medical Associates, Inc.	1985-07-12	24
K842155	SERUM IRON & SERUM IRON BINDING CAPACI	Diagnostic Chemicals, Ltd. (Usa)	1984-08-07	69
K842505	TDX REA IRON DIAGNOSTIC KIT	Abbott Laboratories	1984-08-07	42
K842156	SERUM IRON & SERUM IRON BINDING CAPACITY	Diagnostic Chemicals, Ltd. (Usa)	1984-08-07	69
K840485	TOTAL IRON UIBC/TIBC ASSAY	Somas Medical Industries, Inc.	1984-03-12	35
K834396	DIRECT IRON REAGENT SET	Seragen Diagnostics, Inc.	1984-02-21	69
K830564	FEB TEST	Wako Chemicals USA, Inc.	1983-03-29	34
K820629	CORNING 902 SODIUM POTASSIUM ANALYZER	Corning Medical & Scientific	1982-03-25	17
K810085	IRON KIT	Bio-Analytics Laboratories, Inc.	1981-01-28	15
K792406	ELVI SERUM IRON	Volu Sol Medical Industries	1979-12-07	11

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