Atlas FDA

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

Coeur, Inc. — Predicate Candidate Screening

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

186 daysmedian FDA review time
238 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K170431CT Syringe for Stellant Injectors (with & without Spikes, PrCoeur, Inc.2017-08-181860
K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc.2016-10-061320
K150902330psi Extension Y-Line with Dual Check ValveCoeur, Inc.2015-10-222020
K142745125mL CT SyringeCoeur, Inc.2015-04-011890
K140469MR SYRINGE DUAL PACKCoeur, Inc.2014-07-281530
K133600COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTORCoeur, Inc.2014-04-301560
K120892DISPOSABLE 330PSI EXTENSION LINESCoeur, Inc.2013-06-104440
K113498DISPOSABLE TORQUE DEVICECoeur, Inc.2012-07-202380
K113132DISPOSABLE HEMOSTATIC Y-CONNECTORSCoeur, Inc.2012-01-20880
K090487DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRCoeur, Inc.2009-10-192360
K070798ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORSCoeur, Inc.2007-10-041950
K071196DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROCoeur, Inc.2007-09-061290
K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES ACoeur, Inc.2007-02-091210
K051799DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORSCoeur, Inc.2005-11-021200

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