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

Transamerica Delaval, Inc. — Predicate Candidate Screening

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

104 daysmedian FDA review time

356 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K853996	DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE	Transamerica Delaval, Inc.	1986-05-07	219	0
K851989	DOME, DISPOSABLE, STERILE	Transamerica Delaval, Inc.	1985-08-19	104	0
K851988	ADMINISTRATION SET	Transamerica Delaval, Inc.	1985-08-16	101	0
K851987	FLUSH DEVICE, AUTOMATIC	Transamerica Delaval, Inc.	1985-08-16	101	0
K851986	STOPCOCKS	Transamerica Delaval, Inc.	1985-05-23	16	10
K833171	MONITORING KIT	Transamerica Delaval, Inc.	1984-09-06	356	0
K833170	FLUSH DEVICE	Transamerica Delaval, Inc.	1984-08-12	331	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