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

LDM — Predicate Candidate Screening

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

42 daysmedian FDA review time

161 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K960392	CDM	Bio-Rad	1996-07-08	161	0
K961557	ALLIANCE 2690 SEPARATIONS MODULE	Waters Corporation	1996-07-05	74	0
K942451	BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM	Bio-Rad	1994-11-10	171	0
K922388	WATERS(TM) LC MODULE I FOR CLINICAL USE	Millipore Corp.	1992-09-11	114	0
K920136	WATERS 717 AUTOSAMPLER	Millipore Corp.	1992-02-19	37	0
K903647	MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE	Millipore Corp.	1990-09-11	33	0
K884886	MODEL 250 LIQUID CHROMOTAGRAPHY PUMP	The Perkin-Elmer Corp.	1989-02-02	72	0
K872582	HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM	Millipore Corp.	1987-07-16	16	0
K870949	WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM	Millipore Corp.	1987-04-22	43	0
K862178	ISOPURE LC SYSTEM	The Perkin-Elmer Corp.	1986-07-14	35	0
K850272	WATERS 740 DATA MODULE-PLOTTER INTEGRATOR	Millipore Corp.	1985-03-06	42	0
K850359	WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D	Millipore Corp.	1985-03-05	34	0
K833113	REPORTING INTEGRATOR 3392A	Hewlett-Packard Co.	1983-11-21	69	2
K832375	LIQUID CHROMATOGRAPH 1090 SERIES	Hewlett-Packard Co.	1983-10-14	88	0
K821727	SERIES 10 LIQUID CHROMOTOGRAPH	The Perkin-Elmer Corp.	1982-06-22	11	0
K821219	SERIES 4 LIQUID CHROMATOGRAPH	The Perkin-Elmer Corp.	1982-05-28	31	0
K810304	MODEL LC-85 UV DETECTOR	The Perkin-Elmer Corp.	1981-02-25	20	0
K802031	3390A REPORTING INTEGRATOR	Hewlett-Packard Co.	1980-09-16	26	0
K780933	PREP I AUTOMATED SAMPLE PROCESSOR	E.I. Dupont DE Nemours & Co., Inc.	1978-07-27	50	0

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