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

JJN — Predicate Candidate Screening

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

46 daysmedian FDA review time

163 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K924021	POWER SUPPLY	The Binding Site, Ltd.	1993-01-28	170	0
K924020	ELECTROPHORESIS TANK	The Binding Site, Ltd.	1992-12-28	139	0
K882344	ELECTR-TRANSBLOTTER	The W.E.P. Co.	1989-01-13	220	0
K881852	REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170	Helena Laboratories	1988-07-08	67	0
K882163	HELENA REP GEL PROCESSOR	Helena Laboratories	1988-06-20	27	0
K873352	RAPID ELECTROPHORESIS SYSTEM (REP)	Helena Laboratories	1987-09-08	19	0
K864436	STAVIP 3000	Roseburg SA	1987-03-16	124	0
K861414	ELECTROPHORESIS WORK CENTER (EWC)	Helena Laboratories	1986-08-26	133	0
K841407	ISOGEL AGAROSE	Fmc Corp.	1985-07-16	468	0
K844710	EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD	Logos Scientific, Inc.	1985-01-07	35	0
K842560	OPTIPHOR-10	Gelman Sciences, Inc.	1984-08-10	39	0
K842485	OPTICLEAR	Gelman Sciences, Inc.	1984-08-10	46	0
K841804	ELVI 70 SAFETY CHAMBER	Logos Scientific, Inc.	1984-05-31	30	0
K841288	ELVI 18	Logos Scientific, Inc.	1984-05-02	35	0
K830797	IMMOBILINE SYSTEM LKB 1819	Lkb Instruments, Inc.	1983-08-24	163	0
K823132	SARTOPHOR SYSTEM FOR ELECTROPHORESIS	Sartorius Filters, Inc.	1982-11-27	33	0
K822285	CELLULOSE ACETATE MEMBRANE STRIPS	Sartorius Filters, Inc.	1982-09-21	53	2
K821688	TITAN GEL HIGH RESOLUTION SERUM PROTEIN	Helena Laboratories	1982-06-22	14	0
K821517	TITANAN GEL SERUM PROTEIN ELECTROPHORES	Helena Laboratories	1982-06-10	20	0
K821303	HI-PHORE HIGH RESOLUTION ELECTROPHORES	Gelman Sciences, Inc.	1982-05-12	8	0
K803281	AUTOMATED ELECTROPHORESIS SYSTEM	Helena Laboratories	1981-01-16	18	0
K802395	SPECIAL PROCEDURE AQAROSE FILM	Electrophoresis Corp.	1980-11-26	55	0
K802396	GENERAL PROCEDURE AGAROSE FILM	Electrophoresis Corp. of America	1980-11-26	55	0
K801893	CORNING 60 VOLT POWER SUPPLY	Corning Medical & Scientific	1980-09-16	39	0
K801378	HIPP BUFFER(NON-BARBITAL), P/N	Gelman Sciences, Inc.	1980-07-14	33	0
K792553	AGAROSE BARBITAL-EDTA BUFFER	Electrophoresis Corp. of America	1980-01-29	50	0
K792547	AGAROSE BARBITAL BUFFER	Electrophoresis Corp. of America	1980-01-29	50	0
K791144	BUFFERIZER	Helena Laboratories	1979-08-03	46	0
K791111	AUTOMATED ELECTROPHORESES MACHINE	Gelman Sciences, Inc.	1979-07-30	46	0
K772176	CYSTIC FIBROSIS TESTING INSTRUMENT	Laboratory Equipment Design Co.	1977-12-20	29	0
K771322	ELECTROPHORESIS POWER SUPPLY TESTER	Corning Medical & Scientific	1977-10-18	92	0
K771323	ELECTROPHORESIS OVEN THERMOMETER	Corning Medical & Scientific	1977-08-10	23	0
K761248	ELECTROPHORESIS ACCESSORY MO. 3526	Gilford Instrument Laboratories, Inc.	1976-12-21	8	0
K760131	AGARO-GEL, PRODUCT # A1266	Sigma Chemical Co.	1976-07-20	22	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