Atlas FDA

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

Boston Scientific — Predicate Candidate Screening

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

74 daysmedian FDA review time
198 days90th percentile
58clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross Boston Scientific2026-04-08260
K252910Orca Air/Water and Suction ValvesBoston Scientific2025-10-09271
K251291Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Boston Scientific2025-07-03690
K250468iSLEEVE Introducer SetBoston Scientific2025-03-20300
K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific2024-12-06740
K242507OBSIDIO™ Conformable EmbolicBoston Scientific2024-10-03420
K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System;Boston Scientific2024-08-301960
K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal StBoston Scientific2024-04-2913722
K234002ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific2024-03-13852
K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection GolBoston Scientific2023-11-28900
K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX SBoston Scientific2023-11-22841
K231176Stingray LP CatheterBoston Scientific2023-05-25300
K230503Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableBoston Scientific2023-04-25600
K220866EKOS+ Endovascular DeviceBoston Scientific2022-04-20260
K220629Emerge Monorail PTCA Dilatation CatheterBoston Scientific2022-03-24200
K211080EkoSonic Endovascular DeviceBoston Scientific2021-11-192210
K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser FiberBoston Scientific2021-04-28307
K201178iLab Polaris Multi-Modality Guidance SystemBoston Scientific2020-05-29280
K190184iSLEEVE Introducer SetBoston Scientific2019-03-07340
K180068ORISE GelBoston Scientific2018-09-282621
K180864WATCHMAN TruSeal Access SystemBoston Scientific2018-07-201095
K180102Embozene Color-Advanced MicrospheresBoston Scientific2018-04-19930
K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireBoston Scientific2018-04-12160
K173400ORISE Tissue Retractor SystemBoston Scientific2018-02-091010
K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific2017-10-27280
K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific2017-01-30900
K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific2016-06-14880
DEN150040WallFlex Biliary RX Fully Covered Stent System RMVBoston Scientific2016-06-032800
K152607Express SD Biliary Monorail Premounted Stent SystemBoston Scientific2015-10-27460
K152403Permanent Sled BagBoston Scientific2015-09-22280
K152316iLab Ultrasound Imaging SystemBoston Scientific2015-09-18320
K143193Symmetry and Symmetry Stiff Shaft Balloon Dilatation CatheteBoston Scientific2015-07-242600
K141112STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETERBoston Scientific2014-07-16770
K140630WALLFLEX BILIARY RX STENT SYSTEMBoston Scientific2014-05-23730
K140329RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSBoston Scientific2014-05-15940
K140503FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBERBoston Scientific2014-04-15470
K132914ACUITY PRO LEAD DELIVERY SYSTEMBoston Scientific2014-04-031981
K140323NAVIGATOR HD URETERAL ACCESS SHEATH SETSBoston Scientific2014-03-07250
K132253REMOVABLE PATIENT LEADS ECG CABLEBoston Scientific2013-12-161500
K123765GUIDEZILLA GUIDE EXTENSION CATHETERBoston Scientific2013-03-191020
K113681GLADIATOR PTA BALLOON DILATION CATHETERBoston Scientific2012-01-11270
K112697CHARGER PTA BALLON DILATATION CATHETERBoston Scientific2011-11-30750
K112303RUBICON SUPPORT CATHETERBoston Scientific2011-11-09900
K112701CHARGER BALLOON DILATATION CATHETERBoston Scientific2011-10-25390
K110122MUSTANG BALLOON DILATAION CATHETERSBoston Scientific2011-05-121140
K103751MUSTANG BALLOON DILATATION CATHETERSBoston Scientific2011-03-22890
K102912INTERLOCK FIBERED IDC OCCLUSION SYSTEMBoston Scientific2011-03-031530
K091131PELVIC FLOOR REPAIR SYSTEMBoston Scientific2009-05-08180
K070002BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETERBoston Scientific2007-08-172260
K0709512CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALBoston Scientific2007-06-04610

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