Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Dupont Medical Products · Predicate Candidate Screening

28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

98 daysmedian FDA review time

189 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K952815	DUPONT LIPASE CALIBRATOR	Dupont Medical Products	1995-08-31	72	0
K950920	DUPONT DIMENSION TOTAL PROTEIN METHOD	Dupont Medical Products	1995-08-11	163	0
K952816	LIPASE FLEX REAGENT CARTRIDGE	Dupont Medical Products	1995-07-20	30	1
K952412	DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL	Dupont Medical Products	1995-06-23	31	0
K945280	DUPONT DIMENSION C-REACTIVE PROTEIN METHOD	Dupont Medical Products	1995-03-09	132	0
K944932	PHENOBARBITAL FLEX REAGENT CARTRIDGE	Dupont Medical Products	1994-12-28	83	0
K941050	DUPONT ACA STAR	Dupont Medical Products	1994-11-10	248	0
K943996	DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD	Dupont Medical Products	1994-10-20	65	0
K941146	DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM	Dupont Medical Products	1994-10-03	207	0
K942640	DUPONT DIMENSION AMYLASE METHOD	Dupont Medical Products	1994-09-09	98	0
K942241	DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN	Dupont Medical Products	1994-08-18	101	0
K942240	DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN	Dupont Medical Products	1994-08-17	100	0
K941219	DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR	Dupont Medical Products	1994-08-09	148	0
K943024	KINASE ISOENZYME	Dupont Medical Products	1994-08-02	68	0
K941221	DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORM	Dupont Medical Products	1994-07-20	128	0
K941475	CRONEX REGULAR CASSETTE	Dupont Medical Products	1994-07-20	114	0
K941584	CREATINE KINASE METHOD	Dupont Medical Products	1994-07-06	96	0
K941518	DUPONT CRONEX PORTABLE GRID CASSETTE	Dupont Medical Products	1994-06-06	68	0
K941220	DUPONT ACA PLUS PROLACTIN (PROL) METHOD	Dupont Medical Products	1994-06-03	81	0
K936202	URINARY ALBUMIN TEST PACK	Dupont Medical Products	1994-05-09	131	0
K936201	URINARY ALBUMIN CALIBRATOR	Dupont Medical Products	1994-03-11	72	0
K932732	ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)	Dupont Medical Products	1993-11-15	161	0
K933161	ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN	Dupont Medical Products	1993-10-07	100	0
K933648	ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PAC	Dupont Medical Products	1993-09-24	59	0
K930501	DU PONT ACA NEV/EEV VERIFIER	Dupont Medical Products	1993-08-09	189	0
K932044	DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD	Dupont Medical Products	1993-07-27	91	0
K915106	DIMENSION AR CLINICAL CHEMISTRY SYSTEM	Dupont Medical Products	1992-01-28	76	0
K910354	DU PONT IDENTIFICATION CAMERA	Dupont Medical Products	1991-03-29	59	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