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

JSE — Predicate Candidate Screening

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

26 daysmedian FDA review time

43 days90th percentile

53clearances measured

K-number	Device	Applicant	Decided	Review days
K962265	MLX MICROTITER PLATE LUMINOMETER	Dynatech Laboratories, Inc.	1996-07-25	43
K883996	X-ACT LDC/IND	Pro-Lab, Inc.	1988-10-12	22
K883995	X-ACT UREA/TDA	Pro-Lab, Inc.	1988-10-12	22
K880116	MRVP BROTH	Hardy Media	1988-03-31	85
K880133	MIL MEDIUM	Hardy Media	1988-03-31	85
K874537	KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR	Lakewood Biochemical Co., Inc.	1987-11-20	17
K871096	CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES	bioMerieux, Inc.	1987-04-03	16
K864674	MICRODILUTION IDENTIFICATION PANELS	American Micro Scan	1987-01-05	34
K862393	BIOTIS LITMUS MILK	Otisville Biotech, Inc.	1986-07-03	9
K860413	BIOTIS TSI	Otisville Biotech, Inc.	1986-02-24	21
K860414	BIOTIS ORNITHINE INDOLE MOTILITY MEDIA	Otisville Biotech, Inc.	1986-02-24	21
K860412	BIOTIS SIM MEDIUM	Otisville Biotech, Inc.	1986-02-24	21
K860415	BIOTIS SIMMON CITRATE AGAR	Otisville Biotech, Inc.	1986-02-24	21
K860194	AUSTIN ENTERIC SYSTEM	Austin Biological Laboratories	1986-02-20	29
K850982	CTAPI - NEISSERA SCREEN	Analytical Products, Inc.	1985-03-29	18
K850734	DIFFERENTIAL CULTURE MEDIUM	Roseville Medical Laboratoriesu	1985-03-20	28
K850546	KLIGLER IRON AGAR KIA	Hardy Media	1985-03-11	28
K850548	LYSINE IRON AGAR LIA	Hardy Media	1985-03-11	28
K850551	SIM MEDIUM	Hardy Media	1985-03-11	28
K850547	MOTILITY INDOLE ORNITHINE AGAR	Hardy Media	1985-03-11	28
K843768	BIOTIS KLIGLER IRON AGAR	Otisville Biotech, Inc.	1984-10-10	15
K842424	BIOTIS LD-PRESUMPTO QUADRANT PLATE	Otisville Biotech, Inc.	1984-07-02	12
K842451	RIM STREP KIT	Austin Biological Laboratories	1984-07-02	10
K841204	MULTIPLE BIOCHEMICAL TEST	Smith River Biologicals	1984-04-17	36
K834003	MOTILITY INDOLE ORNITHINE-MEDIUM	Micro Media Laboratories	1983-12-22	31
K834001	KLIGLER IRON AGAR	Micro Media Laboratories	1983-12-22	31
K834002	LYSINE IRON AGAR	Micro Media Laboratories	1983-12-22	31
K834004	MYCOBIOTIC AGAR	Micro Media Laboratories	1983-12-22	31
K834012	SIM MEDIUM	Micro Media Laboratories	1983-12-22	31
K832568	INDOLE NITRATE MEDIUM	Acumedia Manufacturers, Inc.	1983-09-12	41
K830525	API 20GP	Analytical Products, Inc.	1983-05-18	90
K822998	CHRISTENSENS CITRATE SULFIDE AGAR	Granite Diagnostics, Inc.	1982-11-16	35
K823072	LECITHIN LACTOSE AGAR	Granite Diagnostics, Inc.	1982-11-05	17
K821592	TRIPLE SUGAR IRON AGAR SLANT	Hardy Media	1982-07-08	41
K820842	CULTURE MEDIA, NON-SELECTIVE/DIFFER	Blue Ridge Media Co.	1982-04-16	21
K820841	CULTURE MEDIA, MULTIPLE BIOCHEMICAL	Blue Ridge Media Co.	1982-04-16	21
K820810	#4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE	Biomedica, Inc.	1982-04-08	16
K820214	SUCROSE	Dms Laboratories	1982-02-05	10
K812911	BCYE MEDIUM	Gibco Laboratories Life Technologies, Inc.	1981-11-06	18
K812467	PGUA-INDOL MICROTUBE	Carr Microbiologicals	1981-09-14	14
K812466	ONPX-INDOL MEDIUM MICROTUBES	Carr Microbiologicals	1981-09-14	14
K800734	RAPID FERMENTATION AGAR (RFA)	Remel Co.	1980-05-08	36
K792420	SIM MEDIUM	Isle Media and Sterile Products, Inc.	1979-12-31	34
K792425	DECARBOXYLASE MOELLER BASE WITH OR WITH-	Isle Media and Sterile Products, Inc.	1979-12-27	30
K791222	API 20E REAGENT QC	Analytical Products, Inc.	1979-08-22	50
K791473	TRIPLE SUGAR IRON AGAR (TSI AGAR)	Isle Media and Sterile Products, Inc.	1979-08-22	26
K790617	CARBOHYDRATE FERMENTATION MEDIA	Anaerobe Systems	1979-04-23	25
K790230	DENTRIFICATION LACTOSE AGAR	Los Angeles Biological Products	1979-02-21	19
K790232	AGAR, MOTILITY-NITRATE	Los Angeles Biological Products	1979-02-21	19
K781856	PLATE, LD PRESUMPTO	Anaerobe Systems	1978-11-22	16

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