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

CEF — Predicate Candidate Screening

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

51 daysmedian FDA review time

193 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days
K130500	CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONT	Sebia	2013-07-26	150
K972274	SPIFE	Helena Laboratories	1997-10-27	131
K973316	REP SPE VIS-60/40 KIT	Helena Laboratories	1997-10-01	28
K963018	BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS	Bio-Rad	1997-06-04	306
K964453	REP 3 FLUR SPE-60 KIT	Helena Laboratories	1996-12-23	47
K960029	HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,3	Morax	1996-07-17	197
K951536	HYDRAGEL PROTEIN(E) KIT	Sebia	1995-06-30	88
K930317	REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278	Helena Laboratories	1993-08-03	193
K922053	REP SPE PLUS (PONCEAU S) SYSTEM	Helena Laboratories	1992-08-18	106
K922024	REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175	Helena Laboratories	1992-07-23	83
K913315	BIO-RAD TOTAL PROTEIN TEST KIT	Bio-Rad	1992-01-02	161
K913807	REP(R) SPE TEMPLATE 30, 16, & 8	Helena Laboratories	1991-11-27	93
K913058	REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172	Helena Laboratories	1991-10-30	112
K912386	REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165	Helena Laboratories	1991-07-17	82
K911468	REP SPE PLUS (ACID BLUE) SYSTEM	Helena Laboratories	1991-04-16	13
K900251	REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175	Helena Laboratories	1990-02-26	40
K894585	REP TM SPE (PONCEAU S) PROCEDURES	Helena Laboratories	1989-09-13	51
K893211	REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171	Helena Laboratories	1989-06-19	53
K870958	TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091	Helena Laboratories	1987-04-29	50
K843397	CORNING HIGH RESOLUTION PROTEIN ELECTRO	Corning Medical & Scientific	1984-09-14	16
K833855	TITAN GEL SILVER STAIN SYSTEM	Helena Laboratories	1984-02-27	112
K811725	TBG DIAGNOSTIC KIT	Immuno Assay Corp.	1981-07-10	22
K802592	PARAGON SERUM PROTEIN ELECTROPHORESIS	Beckman Instruments, Inc.	1980-11-12	22
K781117	ECA PREP	Electrophoresis Corp. of America	1978-08-10	38
K781120	TRICHLORACETIC ACID 7.5%	Electrophoresis Corp. of America	1978-08-10	38
K781116	ECA BUFFER, PH 816	Electrophoresis Corp. of America	1978-08-10	38
K781118	ECA BUFFER PH 8.8	Electrophoresis Corp. of America	1978-08-10	38
K781123	PONCEAU S	Electrophoresis Corp. of America	1978-08-10	38
K771720	AMIDO BLACK CONCENTRATE	Sigma Chemical Co.	1977-11-03	51

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