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

JTS — Predicate Candidate Screening

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

34 daysmedian FDA review time

68 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days
K960095	BACTIDROP CALCOFLUOR WHITE	Remel Co.	1996-03-19	68
K960090	CALCOFLUOR WHITE STAIN KIT	Remel Co.	1996-03-19	68
K920976	BACTIDROP INDIA INK	Remel Co.	1992-06-09	99
K920975	BACTIDROP CALCOFLUOR WHITE	Remel Co.	1992-06-09	99
K920970	BACTIDROP KOH (10%)	Remel Co.	1992-06-09	99
K893530	IRISTAIN FORMULA 2, PARTS 1 AND 2	Intl. Remote Imaging Systems	1989-06-13	36
K890861	ATS DOBELL & O'CONNOR'S IODINE	Alpha-Tec Systems, Inc.	1989-03-23	30
K890020	ATS LUGOL'S IODINE SOLUTION	Alpha-Tec Systems, Inc.	1989-02-24	51
K884069	SNAP N' STAIN IODINE STAIN	Scientific Device Laboratory, Inc.	1988-10-25	28
K883052	METHENO-STAIN KIT	Scientific Device Laboratory, Inc.	1988-08-30	42
K883061	ATS PARA-SET CARBOL-XYLENE SOLUTION	Alpha-Tech Systems, Inc.	1988-08-17	29
K883049	ATS PARA-SET IODINE ALCOHOL SOLUTION	Alpha-Tec Systems, Inc.	1988-08-17	29
K880989	ATS CRYPTOSPORIDIUM STAIN SET	Alpha-Tec Systems, Inc.	1988-05-13	66
K881598	SDL TRICHROME STAIN	Scientific Device Laboratory, Inc.	1988-05-04	21
K881512	WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY	Wescor, Inc.	1988-04-18	7
K881042	ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)	Alpha-Tec Systems, Inc.	1988-03-30	19
K880718	CALCOFLUOR WHITE STAIN KIT	Remel Co.	1988-03-25	31
K874662	MYCO-FLUOR REAGENT A & B	Scott Laboratories, Inc.	1987-11-25	12
K873413	GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR	Lakewood Biochemical Co., Inc.	1987-10-06	43
K872187	TB KINYOUN CARBOLFUCHSIN	Remel Co.	1987-07-29	51
K872184	TB METHYLENE BLUE	Remel Co.	1987-07-29	51
K872189	METHANOL, ABSOLUTE	Remel Co.	1987-07-29	51
K872185	LIGHT GREEN	Remel Co.	1987-07-29	51
K872186	SULFURIC ACID 10%	Remel Co.	1987-07-29	51
K871606	SPOTTEST FLAGELLA STAIN	Difco Laboratories, Inc.	1987-05-15	21
K871532	TOMTEC GRAM STAINER CRYSTAL VIOLET	Remel Co.	1987-04-29	9
K870988	PRICE'S ACID-FAST STAIN	Devetec, Inc.	1987-03-30	19
K853896	GRAM STAIN KIT	Sigma Diagnostics, Inc.	1985-10-22	32
K851493	KINYOUN ACID FAST STAIN KIT	Accra Laboratories, Inc.	1985-04-29	14
K851494	TWO-STEP ACID FAST BACTERIA STAIN	Accra Laboratories, Inc.	1985-04-29	14
K843429	GRAM STAIN SET W/STABILIZED IODINE	Accra Laboratories, Inc.	1984-09-14	10
K843050	GRAM STAIN	Reagent Laboratory, Inc.	1984-09-11	39
K831060	TRICHROME STAIN	American Micro Scan	1983-06-08	68
K821038	FAST VIOLET B	Dms Laboratories	1982-05-27	44
K813369	GRAM STAIN REAGENTS AND KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1981-12-22	22
K812668	AFB STAIN SET	Carr-Scarborough Microbiologicals, Inc.	1981-09-29	8
K811780	ACCRA-LAB GRAM STAIN SET 55760	Accra Laboratories, Inc.	1981-07-27	34
K781643	ACID FAST KIT	Bioscientific	1978-10-03	8
K781061	DROPPERS, SOLUTION, IODINE	Marion Laboratories, Inc.	1978-08-14	49
K780346	MIF PROCEDURE KIT	Marion Laboratories, Inc.	1978-03-22	21

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