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

The DU Pont Co. — Predicate Candidate Screening

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

56 daysmedian FDA review time

112 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K953477	MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING	The DU Pont Co.	1995-10-07	75
K953475	CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING	The DU Pont Co.	1995-10-07	75
K952891	CRONEX LOW ABSORPTION CASSETTE	The DU Pont Co.	1995-07-13	20
K945125	DUPONT ACA VANCOMYCIN (VANC) METHOD	The DU Pont Co.	1995-03-10	142
K943704	LIPASE CALIBRATOR	The DU Pont Co.	1994-09-14	44
K900492	LABELING CHANGE - VIASPAN(TM) (BELZER UW)	The DU Pont Co.	1990-03-20	46
K885258	ACA THYROXINE (T4 E) METHOD	The DU Pont Co.	1989-02-17	56
K885259	ACA THYRONINE UPTAKE (TU E) METHOD	The DU Pont Co.	1989-02-17	56
K884700	ANALYST THYROXINE (T4) ROTOR	The DU Pont Co.	1989-01-27	79
K884169	DU PONT ANALYST THYROID ROTOR	The DU Pont Co.	1989-01-24	112
K884168	ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.	The DU Pont Co.	1988-11-29	56
K884170	ANALYST THEOPHYLLINE CALIBRATOR	The DU Pont Co.	1988-11-16	56
K884002	ANALYST THEOPHYLLINE ROTOR	The DU Pont Co.	1988-10-31	40

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