Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotronik, Inc. — Predicate Candidate Screening
85 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
244 days90th percentile
85clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261074 | BIOMONITOR IV (471155) | Biotronik, Inc. | 2026-05-01 | 30 | 0 |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peri | Biotronik, Inc. | 2025-04-04 | 25 | 0 |
| K242969 | Pantera Pro; Pantera LEO | Biotronik, Inc. | 2024-10-25 | 29 | 0 |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-4517 | Biotronik, Inc. | 2024-09-12 | 174 | 0 |
| K241711 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2024-07-11 | 27 | 0 |
| K230375 | BIOMONITOR IV | Biotronik, Inc. | 2023-05-19 | 95 | 0 |
| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Biotronik, Inc. | 2023-02-16 | 218 | 0 |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | 2022-07-27 | 30 | 0 |
| K222037 | Selectra Lead Implantation System | Biotronik, Inc. | 2022-07-19 | 8 | 0 |
| K214038 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2022-07-06 | 195 | 0 |
| K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | Biotronik, Inc. | 2021-09-02 | 458 | 0 |
| K201865 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020-12-08 | 155 | 0 |
| K193474 | Selectra 3D Outer Guiding Catheters | Biotronik, Inc. | 2020-10-16 | 305 | 0 |
| K200444 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020-04-23 | 59 | 0 |
| K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter | Biotronik, Inc. | 2019-11-21 | 24 | 0 |
| K191469 | Biotronik Stylets | Biotronik, Inc. | 2019-08-01 | 59 | 0 |
| K190548 | BIOMONITOR III, Remote Assistant III | Biotronik, Inc. | 2019-07-05 | 122 | 0 |
| K183265 | Selectra Catheters, Selectra Accessory Kit | Biotronik, Inc. | 2018-12-13 | 20 | 0 |
| K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + | Biotronik, Inc. | 2017-06-29 | 36 | 0 |
| K170628 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | 2017-03-31 | 29 | 0 |
| K163660 | Pantera LEO | Biotronik, Inc. | 2017-01-26 | 30 | 0 |
| K160985 | Pantera Pro | Biotronik, Inc. | 2016-10-07 | 182 | 0 |
| K152995 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | 2016-04-11 | 181 | 0 |
| K151744 | Passeo-18 Peripheral Dilation Catheter | Biotronik, Inc. | 2015-10-08 | 101 | 0 |
| K152240 | Passeo-14 Peripheral Dilatation Catheter | Biotronik, Inc. | 2015-10-08 | 59 | 0 |
| K151409 | Selectra Catheters and Selectra Accessory Kit | Biotronik, Inc. | 2015-08-07 | 73 | 0 |
| K143503 | BioMonitor | Biotronik, Inc. | 2015-03-19 | 99 | 0 |
| K142379 | Passeo-35 PTA Catheter | Biotronik, Inc. | 2014-12-05 | 101 | 0 |
| K132960 | BIOMONITOR | Biotronik, Inc. | 2014-06-06 | 259 | 0 |
| K131978 | SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL | Biotronik, Inc. | 2013-08-23 | 56 | 0 |
| K130161 | PASSEO-35 | Biotronik, Inc. | 2013-04-23 | 90 | 0 |
| K123324 | SELECTRA 7F CATHETERS | Biotronik, Inc. | 2013-01-11 | 77 | 0 |
| K111839 | SELECTRA ACCESSORY KIT | Biotronik, Inc. | 2011-09-26 | 89 | 0 |
| K112482 | SELECTRA SLITTER TOOL | Biotronik, Inc. | 2011-09-26 | 28 | 0 |
| K111154 | SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SEL | Biotronik, Inc. | 2011-05-23 | 28 | 0 |
| K110461 | SELECTRA CS LEAD INTRODUCER SYSTEM | Biotronik, Inc. | 2011-04-20 | 62 | 0 |
| K101776 | SCOUTPRO ACS | Biotronik, Inc. | 2010-07-23 | 28 | 0 |
| K101282 | SCOUTPRO HEMOSTATIC VALVE | Biotronik, Inc. | 2010-07-21 | 76 | 0 |
| K093303 | SCOUTPRO 7F LONG CATHETERS | Biotronik, Inc. | 2009-11-20 | 30 | 0 |
| K083674 | PK-141 PATIENT CABLE | Biotronik, Inc. | 2009-04-01 | 111 | 0 |
| K082935 | VISION WIRE CORONARY GUIDEWIRE | Biotronik, Inc. | 2008-12-04 | 64 | 0 |
| K082933 | PASSEO-35 PTA CATHETER | Biotronik, Inc. | 2008-11-03 | 33 | 0 |
| K080988 | SCOUTPRO CS LEAD INTRODUCER SYSTEM | Biotronik, Inc. | 2008-05-07 | 30 | 0 |
| K072329 | SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED | Biotronik, Inc. | 2008-03-25 | 218 | 0 |
| K073230 | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS | Biotronik, Inc. | 2007-12-20 | 35 | 0 |
| K072765 | PASSEO 18 | Biotronik, Inc. | 2007-12-12 | 75 | 0 |
| K071665 | SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 | Biotronik, Inc. | 2007-07-18 | 30 | 0 |
| K061212 | BIOTRONIK ENDOCARDIAL PACING LEADS | Biotronik, Inc. | 2006-07-10 | 70 | 0 |
| K060807 | SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM | Biotronik, Inc. | 2006-04-24 | 31 | 0 |
| K060655 | SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 96 | Biotronik, Inc. | 2006-04-04 | 22 | 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