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

Thoratec Laboratories Corp. — Predicate Candidate Screening

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

69 daysmedian FDA review time

175 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K001927	VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER	Thoratec Laboratories Corp.	2000-12-18	175
K001926	VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURV	Thoratec Laboratories Corp.	2000-09-22	88
K851495	THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY	Thoratec Laboratories Corp.	1985-08-01	108
K833714	RESPIRATORY ASSESSMENT SYSTEM	Thoratec Laboratories Corp.	1983-12-29	69
K833265	RESPIRATORY FLOW MODULE	Thoratec Laboratories Corp.	1983-11-28	68
K831557	INTRAOPERATIVE AUTOTRANSFUSION SYS	Thoratec Laboratories Corp.	1983-08-24	100
K823449	RESPIRATORY GAS ANALYZER	Thoratec Laboratories Corp.	1983-01-05	54
K823287	RESPIRATORY CIRCUIT ADAPTOR	Thoratec Laboratories Corp.	1982-12-09	35
K822769	THORATEC GAS SAMPLING CONNECTOR	Thoratec Laboratories Corp.	1982-10-06	22
K780247	IMPCO DISPOSABLE AORTIC PUNCH	Thoratec Laboratories Corp.	1978-02-27	14

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