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

Oldelft Corp. of America · Predicate Candidate Screening

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

148 daysmedian FDA review time

285 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K980296	OLDELFT DIGIDELCA	Oldelft Corp. of America	1998-04-17	80
K973219	AMBER DU	Oldelft Corp. of America	1997-10-08	42
K946128	SIMULIX-HP	Oldelft Corp. of America	1995-05-12	148
K950037	N 800 HF	Oldelft Corp. of America	1995-02-15	42
K932848	SIMULIX-MC CT EXTENSION	Oldelft Corp. of America	1994-03-22	285
K923584	THERAPAX DXT 300 SERIES 3	Oldelft Corp. of America	1993-01-15	179
K914784	PAPILLION PROCTOSCOPE	Oldelft Corp. of America	1992-06-05	226
K912466	OLDELFT SIMULIX-MC	Oldelft Corp. of America	1991-06-28	24
K892659	ELECTRODELCA	Oldelft Corp. of America	1989-11-21	222

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