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

3t Medical Systems, LLC · Predicate Candidate Screening

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

88 daysmedian FDA review time

484 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K072697	3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES	3t Medical Systems, LLC	2007-12-20	87	0
K022287	3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS	3t Medical Systems, LLC	2002-09-23	70	0
K020768	3T VESSEL CANNULAS	3t Medical Systems, LLC	2002-08-23	169	0
K020365	3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE	3t Medical Systems, LLC	2002-05-03	88	0
K001245	3T L. V. CONTROL VALVE	3t Medical Systems, LLC	2001-08-15	484	36

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