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

KIE — Predicate Candidate Screening

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

35 daysmedian FDA review time

106 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K964588	WATERS 515 HPLC PUMP (515)	Waters Corporation	1996-11-29	14
K935666	PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP	The Perkin-Elmer Corp.	1994-04-26	151
K924347	WATERS(TM) 996 PDA	Millipore Corp.	1992-12-11	106
K914841	CHROMATOGRAPHY CLINICAL USE 75JQR	Millipore Corp.	1991-12-10	46
K911299	EQUIPMENT/MATERIAL DECONTAMINATING KIT	Rohm and Haas Co.	1991-04-08	14
K862506	THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR	Millipore Corp.	1986-07-29	28
K844947	EMIT ANCILLARY REAGENTS	Syva Co.	1985-06-28	190
K844949	SYVA SAMPLE SEAL	Syva Co.	1985-02-15	57
K800556	DIFFERENTIAL REFRACTIVE INDEX DETECTOR	Hewlett-Packard Co.	1980-03-25	13
K800516	DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM.	E.I. Dupont DE Nemours & Co., Inc.	1980-03-19	14
K800289	LDC SPECTROMONITOR III	Laboratory Data Control	1980-02-26	15
K800046	LDC CHROMATOGRAPHY ACCESSORY MODULE B	Laboratory Data Control	1980-02-25	47
K800048	LDC CONSTAMETRIC III HIGHT PRESS. SOL.	Laboratory Data Control	1980-01-29	20
K800047	LDC UVIII FIXED WAVELENGTH ULTRAVIOLET	Laboratory Data Control	1980-01-21	12
K791661	SYSTEM CONTROLLER 720 SERIES	Waters Assoc., Inc.	1979-09-24	34
K782175	CARTRIDGE HOLDER, RCM 100	Waters Assoc., Inc.	1979-02-15	49
K790145	SOLVENT DELIVERY SYSTEM	Waters Assoc., Inc.	1979-02-15	28
K781915	DATA MODULE	Waters Assoc., Inc.	1979-01-10	57
K781771	DETECTOR, MODEL 79875A, VARIABLE	Hewlett-Packard Co.	1978-12-20	68
K781379	MODEL 5000, LIQUID CHROMATOGRAPHY	Varian Assoc., Inc.	1978-09-14	34
K772364	AUTO. SAMPLING SYSTEM	Hewlett-Packard Co.	1978-01-05	9
K771156	MONITOR, LIQ. CHROMATOGRAPHY LC-15 UV	The Perkin-Elmer Corp.	1977-08-02	35
K770638	DETECTOR, UV, MOLEL GC-55	Peokin-Elmer Corp.	1977-06-24	81
K761351	L080 SERIES LIQUID CHROMATOGRAPH	Hewlett-Packard Co.	1977-02-02	36
K761219	SERIES II LIQUID CHROMATOGRAPH	The Perkin-Elmer Corp.	1977-02-01	56

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