Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boston Scientific Corporation · Predicate Candidate Screening
236 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
208 days90th percentile
236clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-07-24 | 7 | 0 |
| K262165 | FARADRIVE™ Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | 2026-07-24 | 28 | 0 |
| K261488 | OBSIDIO Conformable Embolic | Boston Scientific Corporation | 2026-07-24 | 79 | 0 |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-W | Boston Scientific Corporation | 2026-07-10 | 28 | 0 |
| K260428 | RIVOS™ EUS Access Device (M00553900) | Boston Scientific Corporation | 2026-06-17 | 127 | 0 |
| K260100 | MOSES Raydar™ | Boston Scientific Corporation | 2026-05-18 | 125 | 0 |
| K260771 | TruSelect™ 2.6 Microcatheter | Boston Scientific Corporation | 2026-05-15 | 67 | 0 |
| K251273 | Asurys Fluid Management System | Boston Scientific Corporation | 2026-03-27 | 337 | 0 |
| K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-03-13 | 28 | 1 |
| K260119 | SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation | 2026-02-10 | 27 | 0 |
| K253376 | OBSIDIO™ Conformable Embolic (M0013972101010) | Boston Scientific Corporation | 2025-10-30 | 30 | 0 |
| K252529 | Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L | Boston Scientific Corporation | 2025-10-30 | 80 | 0 |
| K252547 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2025-10-28 | 77 | 1 |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | 2025-09-26 | 14 | 0 |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - St | Boston Scientific Corporation | 2025-09-24 | 28 | 0 |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Inse | Boston Scientific Corporation | 2025-09-12 | 28 | 0 |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber | Boston Scientific Corporation | 2025-07-09 | 30 | 0 |
| K250310 | VIKING™ Fixed Curve Diagnostic Catheter | Boston Scientific Corporation | 2025-06-27 | 144 | 0 |
| K250584 | Rezum System | Boston Scientific Corporation | 2025-06-11 | 104 | 0 |
| K251344 | OptiMap™ System | Boston Scientific Corporation | 2025-05-28 | 28 | 0 |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Per | Boston Scientific Corporation | 2025-04-15 | 28 | 0 |
| K250517 | Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M00 | Boston Scientific Corporation | 2025-03-21 | 28 | 0 |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Re | Boston Scientific Corporation | 2025-02-06 | 27 | 0 |
| K242960 | AdVance™ XP Male Sling System (720163-03) | Boston Scientific Corporation | 2024-11-15 | 51 | 0 |
| K240366 | EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic | Boston Scientific Corporation | 2024-11-01 | 269 | 0 |
| K241227 | RHYTHMIA HDx™ Mapping System | Boston Scientific Corporation | 2024-08-29 | 119 | 0 |
| K241683 | Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390 | Boston Scientific Corporation | 2024-07-10 | 29 | 0 |
| K241598 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - St | Boston Scientific Corporation | 2024-07-01 | 27 | 0 |
| K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | 2024-04-04 | 122 | 9 |
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery Syst | Boston Scientific Corporation | 2024-03-08 | 78 | 0 |
| K240018 | WATCHMAN TruSteer Access System (M635TU90050) | Boston Scientific Corporation | 2024-02-01 | 30 | 1 |
| K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflecti | Boston Scientific Corporation - | 2023-12-12 | 28 | 0 |
| K233248 | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | 2023-12-11 | 74 | 3 |
| K233503 | 14F iSLEEVE Introducer Set | Boston Scientific Corporation | 2023-11-30 | 30 | 1 |
| K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mm | Boston Scientific Corporation | 2023-10-27 | 28 | 18 |
| K233207 | Polaris X™ Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023-10-27 | 29 | 0 |
| K232651 | BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023-09-29 | 29 | 0 |
| K230884 | AVVIGO'+ Multi-Modality Guidance System | Boston Scientific Corporation | 2023-09-26 | 180 | 22 |
| DEN230019 | AXIOS Stent and Electrocautery-Enhanced Delivery System (10m | Boston Scientific Corporation | 2023-08-18 | 144 | 0 |
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphinc | Boston Scientific Corporation | 2023-08-14 | 24 | 0 |
| K223633 | Rubicon™ Control Support Catheter (H749394323506A1) | Boston Scientific Corporation | 2023-08-08 | 246 | 0 |
| K230551 | Visual-ICE Cryoablation System | Boston Scientific Corporation | 2023-08-08 | 161 | 0 |
| K230269 | Ultraflex™ Tracheobronchial Stent System | Boston Scientific Corporation | 2023-07-14 | 164 | 0 |
| K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ult | Boston Scientific Corporation | 2023-06-29 | 30 | 0 |
| K230706 | EMBOLD™ Soft Detachable Coil System | Boston Scientific Corporation | 2023-06-27 | 105 | 0 |
| K231533 | Habib EndoHPB | Boston Scientific Corporation | 2023-06-21 | 26 | 0 |
| K223469 | WallFlex™ Biliary RX Stent System | Boston Scientific Corporation | 2023-06-15 | 210 | 0 |
| K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD C | Boston Scientific Corporation | 2023-05-18 | 86 | 0 |
| K223824 | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARM | Boston Scientific Corporation | 2023-03-22 | 91 | 1 |
| K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod | Boston Scientific Corporation | 2023-03-02 | 297 | 0 |
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