Atlas FDA

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

OWQ — Predicate Candidate Screening

31 FDA 510(k) clearances under this product code; the 50 most recent screened below.

147 daysmedian FDA review time
263 days90th percentile
31clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, Sterilmed, Inc.2026-06-291890
K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco DSurgical Instrument Service and Savings, Inc.2025-06-051001
K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-867Northeast Scientific, Inc.2025-05-12740
K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F UltrasSurgical Instrument Service and Savings, Inc.2025-03-101610
K234064Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F UltrasoSurgical Instrument Service and Savings, Inc.2024-09-102632
K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, Inc.2023-12-151512
K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS CatheterVein 360, LLC2023-10-24600
K230928Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterVein 360, LLC2023-08-251440
K231621Reprocessed ViewFlex Xtra ICE Catheter (D087031)Stryker Sustainability Solutions2023-07-25530
K231588ViewFlex™ Eco Reprocessed ICE CatheterABBOTT MEDICAL2023-06-30290
K230584Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC2023-06-06960
K230934ViewFlex™ Eco Reprocessed ICE CatheterABBOTT MEDICAL2023-05-03300
K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNortheast Scientific, Inc.2023-02-031270
K222217ViewFlex Xtra Reprocessed ICE CatheterABBOTT MEDICAL2022-12-191470
K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterInnovative Health, LLC2022-05-254470
K202042Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC2020-11-201200
K190478Reprocessed ViewFlex™ Xtra ICE CatheterSterilmed, Inc.2019-11-142600
K182238Reprocessed ViewFlex Xtra ICE CatheterStryker Sustainability Solutions2019-05-082611
K181126Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC2019-01-182630
K173262Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC2018-03-061460
K163560Reprocessed AcuNav Diagnostic Ultrasound CatheterInnovative Health, LLC2017-07-122050
K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC2017-06-161200
K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SouSterilmed, Inc.2016-11-211540
K153090Reprocessed Diagnostic Ultrasound CatheterInnovative Health, LLC2016-03-101360
K121913REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETERStryker Sustainability Solutions, Inc.2012-12-201710
K110076REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERSterilmed, Inc.2011-08-182191
K092425REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTRAscent Healthcare Solutions2009-10-21750
K063076REPROCESSED DIAGNOSTIC ULTRASOUND CATHETERAscent Healthcare Solutions2007-03-291740
K033436REPROCESSED DIAGNOSTIC ULTRASOUND CATHETERAlliance Medical Corp.2005-03-165050
K043453STERILEMED REPROCESSED IVUS IMAGING CATHETERSterilmed, Inc.2005-03-01763
K012537REPROCESSED IMAGING CATHETERSSterilmed, Inc.2002-10-114300

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