Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boston Scientific Corp — Predicate Candidate Screening
432 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
215 days90th percentile
432clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1. | Boston Scientific Corp | 2024-10-18 | 7 | 0 |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | 2023-08-19 | 103 | 3 |
| K152853 | WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT | Boston Scientific Corp | 2015-11-20 | 52 | 0 |
| K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Boston Scientific Corp | 2015-08-05 | 140 | 0 |
| K150303 | XXL Vascular Balloon Dilatation Catheter | Boston Scientific Corp | 2015-06-15 | 129 | 0 |
| K150186 | Chariot Guiding Sheath | Boston Scientific Corp | 2015-06-05 | 129 | 1 |
| K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Conne | Boston Scientific Corp | 2015-05-29 | 73 | 3 |
| K141820 | JAGWIRE HIGH PERFORMANCE GUIDWIRE | Boston Scientific Corp | 2014-10-21 | 106 | 0 |
| K141335 | EXPEL APD DRAINAGE CATHETER SYSTEM | Boston Scientific Corp | 2014-10-17 | 149 | 2 |
| K141344 | EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTE | Boston Scientific Corp | 2014-10-17 | 148 | 0 |
| K141150 | PTA BALLOON DILATATION CATHETER | Boston Scientific Corp | 2014-09-25 | 143 | 0 |
| K142259 | Direxion Torqueable Microcatheter | Boston Scientific Corp | 2014-09-10 | 27 | 0 |
| K140273 | EQUALIZER OCCLUSION BALLOON CATHETER | Boston Scientific Corp | 2014-07-22 | 169 | 0 |
| K140726 | CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAP | Boston Scientific Corp | 2014-07-21 | 119 | 0 |
| K141185 | V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM | Boston Scientific Corp | 2014-06-06 | 30 | 0 |
| K140495 | LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELE | Boston Scientific Corp | 2014-04-17 | 49 | 0 |
| K140745 | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | 2014-04-17 | 23 | 1 |
| K140288 | TRUEPATH CTO DEVICE | Boston Scientific Corp | 2014-04-16 | 70 | 0 |
| K140673 | INSERTION TOOL | Boston Scientific Corp | 2014-04-16 | 29 | 0 |
| K132810 | GLADIATOR ELITE PTA BALLOON DILATATION CATHETER | Boston Scientific Corp | 2014-02-28 | 172 | 0 |
| K133566 | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL | Boston Scientific Corp | 2013-12-20 | 30 | 0 |
| K133208 | INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM | Boston Scientific Corp | 2013-11-14 | 27 | 0 |
| K131700 | SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, | Boston Scientific Corp | 2013-11-04 | 146 | 0 |
| K131914 | OFFROAD RE-ENTRY CATHETER SYSTEM | Boston Scientific Corp | 2013-10-31 | 127 | 0 |
| K132990 | OCCLUSION BALLOON CATHETER | Boston Scientific Corp | 2013-10-22 | 28 | 0 |
| K132947 | DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS | Boston Scientific Corp | 2013-10-18 | 29 | 0 |
| K132430 | STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER | Boston Scientific Corp | 2013-10-17 | 73 | 0 |
| K132578 | INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM | Boston Scientific Corp | 2013-09-13 | 28 | 0 |
| K130484 | MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIAR | Boston Scientific Corp | 2013-08-09 | 165 | 0 |
| K130391 | EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORA | Boston Scientific Corp | 2013-07-10 | 145 | 0 |
| K130909 | GATEWAY ADVANAGE Y-ADAPTER | Boston Scientific Corp | 2013-05-16 | 45 | 0 |
| K123621 | OPTICROSS 40 MHZ CORONARY IMAGING CATHETER | Boston Scientific Corp | 2013-04-15 | 143 | 1 |
| K130243 | ILAB ULTRASOUND IMAGING SYSTEM | Boston Scientific Corp | 2013-03-01 | 29 | 0 |
| K123424 | MDU5 PLUS STERILE BAG | Boston Scientific Corp | 2013-02-20 | 105 | 0 |
| K123535 | ILAB ULTRASOUND IMAGING SYSTEM | Boston Scientific Corp | 2013-01-15 | 60 | 0 |
| K122794 | UPSYLON Y MESH | Boston Scientific Corp | 2012-12-18 | 97 | 0 |
| K122649 | NAVIGATOR HD URETERAL ACCESS SHEATH SET | Boston Scientific Corp | 2012-12-12 | 104 | 0 |
| K123214 | ENCORE 26 ADVANTAGE KIT | Boston Scientific Corp | 2012-11-13 | 29 | 0 |
| K122924 | CRE FIXED WIRE BALLON DILATION CATHETER | Boston Scientific Corp | 2012-10-24 | 30 | 0 |
| K121754 | BLUE SUI SLING | Boston Scientific Corp | 2012-10-10 | 118 | 0 |
| K121614 | NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHET | Boston Scientific Corp | 2012-09-18 | 109 | 3 |
| K121694 | IMAGER II ANGIOGRAPHIC CATHETER | Boston Scientific Corp | 2012-09-14 | 99 | 3 |
| K121774 | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROT | Boston Scientific Corp | 2012-09-13 | 87 | 0 |
| K121196 | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILAT | Boston Scientific Corp | 2012-08-31 | 134 | 0 |
| K122394 | RUBICON 18 SUPPORT CATHETER | Boston Scientific Corp | 2012-08-30 | 23 | 0 |
| K122203 | TRUETOME | Boston Scientific Corp | 2012-08-17 | 23 | 0 |
| K121667 | NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) | Boston Scientific Corp | 2012-08-13 | 68 | 0 |
| K121048 | ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED | Boston Scientific Corp | 2012-08-03 | 119 | 0 |
| K120495 | IMPULSE AND EXPO ANGIOGRAPHIC CATHETER | Boston Scientific Corp | 2012-05-21 | 94 | 0 |
| K121186 | RADIAL JAW 4 PULMONARY BIOPSY FORCEPS | Boston Scientific Corp | 2012-05-16 | 28 | 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