Atlas FDA

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

Medsource International, LLC — Predicate Candidate Screening

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

127 daysmedian FDA review time
270 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, aMedsource International, LLC2023-09-152700
K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe CoMedsource International, LLC2016-11-031270
K150333MedSource Sharps DartMedsource International, LLC2015-05-08870
K140442MEDSOURCE SELECTABLE IV SETMedsource International, LLC2014-04-22600
K140402MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATIMedsource International, LLC2014-04-03440
K131555MEDSOURCE IV SAFETY CATHETERMedsource International, LLC2014-01-312470
K120424MEDSOURCE IV ADMINSTRATION SETMedsource International, LLC2012-07-111490
K080339MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)Medsource International, LLC2008-10-272620
K081516MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORTMedsource International, LLC2008-08-26880

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