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

CEJ — Predicate Candidate Screening

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

30 daysmedian FDA review time

98 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K043267	POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2	Randox Laboratories, Ltd.	2005-02-10	76
K943026	POTASSIUM QVET	Prisma Systems	1994-12-09	165
K904033	REFLOTRON POTASSIUM TEST TABS	Boehringer Mannheim Corp.	1990-11-06	67
K902574	POTASSIUM REAGENT SET	Tech-Co, Inc.	1990-07-10	29
K883586	TECHNICON RA-100 SYSTEM POTASSIUM	Technicon Instruments Corp.	1988-11-29	98
K883585	TECHNICON ASSIST POTASSIUM	Technicon Instruments Corp.	1988-11-29	98
K881440	IQ POTASSIUM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988-05-27	52
K880339	EASY-TEST POTASSIUM K ITEM NUMBER 19XXX	Em Diagnostic Systems, Inc.	1988-02-25	30
K863486	POTASSIUM TEST	Sclavo, Inc.	1986-09-29	20
K861713	SERUM POTASSIUM REAGENT SET	Sterling Diagnostics, Inc.	1986-05-23	18
K853404	QCA POTASSIUM TEST KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1985-08-23	11
K850258	BCS POTASSIUM TURBIDIMETRIC TEST	Bioclinical Systems, Inc.	1985-02-07	16
K832553	POTASSIUM TEST KIT	Mallinckrodt Critical Care	1983-09-20	50
K813608	POTASSIUM REAGENT SET	Diagnostic Specialties	1982-01-22	24
K812677	UNITEST-POTASSIUM	Biodynamics Corp.	1981-10-02	10
K811661	POTASSIUM TEST	King Diagnostics, Inc.	1981-06-25	10

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