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

JTO — Predicate Candidate Screening

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

39 daysmedian FDA review time

119 days90th percentile

244clearances measured

K-number	Device	Applicant	Decided	Review days
K050352	IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT	Ameritek Research, LLC	2005-09-01	202
K970832	PYR SWAB	Remel, Inc.	1997-04-24	48
K970834	GRAM SWAB	Remel, Inc.	1997-04-17	41
K970833	INDOLE SWAB	Remel, Inc.	1997-04-02	26
K970009	LYFO(TM) DIFFERENTIAL DISK-BACITRACIN	Microbiologics, Inc.	1997-02-06	35
K962966	IDS RAPID CB PLUS SYSTEM	Innovative Diagnostic Systems, Inc.	1996-10-08	70
K961191	COLISCREEN	Hardy Diagnostics	1996-06-17	83
K960996	M. CAT BUTYRATE DISK	Hardy Diagnostics	1996-04-18	37
K955826	GIBSON ID-M. CAT.	Gibson Laboratories, Inc.	1996-02-29	65
K954783	DRYSLIDE CARTARRHALIS	Difco Laboratories, Inc.	1996-02-06	112
K954812	LYFO(TM) DIFFERIENTAL DISK-PYR	Microbiologics, Inc.	1995-12-20	62
K953247	GIBSON ID A.E. TEST	Gibson Laboratories, Inc.	1995-11-20	132
K951889	LYFO(TM) DIFFERENTIAL DISK	Microbiologics, Inc.	1995-08-24	122
K950346	B-L RED(TM) DISCS	Oxis Intl., Inc.	1995-05-05	98
K945883	LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN	Microbiologics, Inc.	1995-04-24	144
K945882	LYFO(TM) DIFFERENTIAL DISK-BILE	Microbiologics, Inc.	1995-04-24	144
K945880	LYFO(TM) DIFFERENTIAL DISK-SPS	Microbiologics, Inc.	1995-04-24	144
K945881	LYFO(TM) DIFFERENTIAL DISK-STERILE DISK	Microbiologics, Inc.	1995-04-24	144
K934130	SWABZYME OXIDASE	E-Y Laboratories, Inc.	1994-09-14	394
K940161	B-LACTAMASE REAGENT TUBES	E-Y Laboratories, Inc.	1994-09-09	240
K934125	GONOCHEK-II, MODIFICATION	E-Y Laboratories, Inc.	1994-09-09	393
K940162	GONOCHEK II REAGENT TUBES	E-Y Laboratories, Inc.	1994-09-09	240
K940020	STREP-A-CHEK(TM) REAGENT STRIPS	E-Y Laboratories, Inc.	1994-08-26	235
K940124	EY-20 REAGENT TUBES	E-Y Laboratories, Inc.	1994-08-26	228
K934129	STREP-A-CHEK	E-Y Laboratories, Inc.	1994-08-26	379
K941111	STREP-SURE A/E	Clinical Standards Laboratories, Inc.	1994-08-02	148
K941016	DISPENS-O-DISC(TM) NITROCEFIN	Difco Laboratories, Inc.	1994-06-30	119
K936021	BACTICARD STREP	Remel Co.	1994-05-20	154
K936034	SERIM PYLORITEK REAGENT STRIPS	Serim Research Corp.	1994-04-21	127
K934986	BACTICARD E. COLI	Remel Co.	1994-02-23	127
K931865	PYR TEST KIT	Hardy Diagnostics	1993-12-15	245
K932752	VISI-SPOT	J.S. Medical Assoc.	1993-11-05	170
K933514	BACTICARD STREP	Remel Co.	1993-10-28	100
K931862	NINHYDRIN REAGENT	Hardy Diagnostics	1993-06-15	62
K931414	CATALASE REAGENT	Hardy Diagnostics	1993-05-12	90
K930693	OXYSTRIP	Hardy Diagnostics	1993-05-12	91
K931413	FERRIC CHLORID REAGENT, 10%	Hardy Diagnostics	1993-05-11	89
K930878	BACTIDROP(TM) MUCAP	Remel Co.	1993-05-11	81
K930720	VOGUES-PROSKAUER REAGENT A & B	Hardy Diagnostics	1993-04-23	71
K930717	NITRATE REAGENTS A, B AND C	Hardy Diagnostics	1993-04-23	71
K930718	INDOLE SPOT & INDOLE KOVACS REAGENT	Hardy Diagnostics	1993-04-23	71
K926255	BBL NITRATE A, B REAGENT DROPPERS	Becton Dickinson Microbiology Systems	1993-01-26	39
K926256	BBL NINHYDRIN REAGENT DROPPERS	Becton Dickinson Microbiology Systems	1993-01-26	39
K926254	BBL PYR REAGENT DROPPERS	Becton Dickinson Microbiology Systems	1993-01-26	39
K925747	DRYSLIDE(TM) INDOLE	Difco Laboratories, Inc.	1993-01-15	63
K923700	INDOXYL ACETATE DISK	Remel Co.	1992-10-05	73
K923827	LAP DISK	Remel Co.	1992-09-28	60
K920973	BACTIDROP INDOLE (ERLICH'S)	Remel Co.	1992-06-19	109
K921583	DRYSLIDE(TM), PYR	Difco Laboratories, Inc.	1992-06-19	102
K920971	BACTIDROP NINHYDRIN	Remel Co.	1992-05-22	81

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