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

JJR — Predicate Candidate Screening

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

43 daysmedian FDA review time

103 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K990971	EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816	Medica Corp.	1999-04-27	35
K960592	ELECTROLYTE STANDARDS	Phoenix Diagnostics, Inc.	1996-05-13	91
K955630	RNA MEDICAL HEMAT CONTROL	Bionostics, Inc.	1996-03-01	81
K951435	AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL	Aalto Scientific, Ltd.	1995-05-02	36
K943925	SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING	Quantimetrix Corp.	1994-10-04	53
K934641	I-STAT CONTROL LEVELS 1,2,3	I-Stat Corp.	1993-12-09	79
K912513	ELECTROLYTE CONTROL	Verichem Laboratories, Inc.	1991-07-19	43
K902266	ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)	Phoenix Diagnostics, Inc.	1990-06-06	16
K894576	CIBA CORNING CERTAIN LYTE	Ciba Corning Diagnostics Corp.	1989-10-30	101
K895582	QCLYTE PROTEIN-BASED ISE CONTROL	Baxter Healthcare Corp	1989-10-04	19
K881773	DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET	Casco Standards	1988-06-10	45
K881655	SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL	Biomedical Research & Development Laboratories, Inc.	1988-05-27	42
K880710	PROTEIN BASE ISE CONTROL	Bionostics, Inc.	1988-03-24	31
K863333	AVL ISE-TROL ELECTROLYTE CONTROL	Avl Scientific Corp.	1986-09-29	32
K834505	HUMAN SERUM ELECTROLYTE CONTROL-LIQUID	Quantimetrix Corp.	1984-04-13	114
K831389	STAT-TRAK LIQUID ELECTROLYTE CONTROL	United Diagnostics, Inc.	1983-08-10	103
K792196	8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO	Photovolt Corp.	1979-11-13	12

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