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

Arrow International, Inc. — Predicate Candidate Screening

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

86 daysmedian FDA review time
175 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABArrow International, Inc.2020-05-273011
K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.2020-04-09301
K190101UltraFlex IABArrow International, Inc.2019-06-281571
K190117Fiberoptix IABArrow International, Inc.2019-06-131400
K162820AC3 Series IABP SystemArrow International, Inc.2017-03-311752
K141051VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRArrow International, Inc.2014-07-07741
K130192NEXTSTEP RETROGRADEArrow International, Inc.2013-05-101050
K130876CG+ ARROW PICC POWERED BY ARROW VPS STYLETArrow International, Inc.2013-04-26282
K122690ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLEArrow International, Inc.2012-12-211080
K122027ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETERArrow International, Inc.2012-08-28481
K113277ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CEArrow International, Inc.2012-06-212272
K080604PRESSURE INJFECTABLE PICCArrow International, Inc.2008-06-271150
K073451PRESSURE INJECTABLE PICCArrow International, Inc.2008-01-15366
K071538ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABArrow International, Inc.2007-08-308627
K061289ARROW PRESSURE INJECTABLE PICCArrow International, Inc.2006-08-241073
K041740SILICONE COATED GUIDEWIREArrow International, Inc.2004-10-151090
K040666STEP-TIP CHRONIC HEMODIALYSIS CATHETERArrow International, Inc.2004-05-14600
K040078CANNON II PLUSArrow International, Inc.2004-02-133019
K030937STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02Arrow International, Inc.2003-04-23291

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