Data / Medical devices / United States / Biotronik, Inc.
Biotronik, Inc.: FDA-registered device maker in Lake Oswego, OR, United States, 22 510(k) clearances and 6 PMA approvals
Biotronik, Inc. is registered with the FDA (registration 1028232) in Lake Oswego, OR, United States. It lists 25 device types. The FDA files 22 510(k) clearances and 6 PMA approvals under its listings, the newest dated April 4, 2025. 8 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1028232
- Address
- 6024 Jean RD., Lake Oswego, OR, United States, 97035
- Owner or operator
- BIOTRONIK, INC. (1028232)
- Roles
- Repackager or relabeler
- First device listed
- April 11, 2006
- Registered through
- 2027
- Brand names listed
- A1-CS-SB, ACD 300, AKKU-1, AcQRate DX Fixed Curve Catheter, AcQRate Dx Steerable Catheter, Acticor Sky, Acticor family, Amvia and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 4, 2025 | K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | LIT | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| September 12, 2024 | K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | DQY | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| May 19, 2023 | K230375 | BIOMONITOR IV | MXD | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| July 27, 2022 | K221856 | BIOMONITOR IIIm, BIOMONITOR III | MXD | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| July 19, 2022 | K222037 | Selectra Lead Implantation System | DQY | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| October 15, 2021 | K212593 | ViaCath, AcQRate Dx Steerable Catheter | DRF | Substantially Equivalent | Biotronick, Inc. | accessdata.fda.gov |
| September 2, 2021 | K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | DRF | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| October 16, 2020 | K193474 | Selectra 3D Outer Guiding Catheters | DQY | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| April 23, 2020 | K200444 | Biomonitor III, Biomonitor IIIm | MXD | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| November 21, 2019 | K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | DQY | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| August 1, 2019 | K191469 | Biotronik Stylets | DRB | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| July 5, 2019 | K190548 | BIOMONITOR III, Remote Assistant III | MXD | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| April 11, 2016 | K152995 | BioMonitor 2-AF, BioMonitor 2-S | MXD | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| August 7, 2015 | K151409 | Selectra Catheters and Selectra Accessory Kit | DQY | Unknown | Biotronik, Inc. | accessdata.fda.gov |
| March 19, 2015 | K143503 | BioMonitor | MXD | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| July 7, 2009 | K083094 | STREAMER POLYMER GUIDEWIRE | DQX | Substantially Equivalent | Brivant, Ltd. | accessdata.fda.gov |
| April 1, 2009 | K083674 | PK-141 PATIENT CABLE | DTC | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| December 4, 2008 | K082935 | VISION WIRE CORONARY GUIDEWIRE | DQX | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| January 18, 2001 | K003454 | A1-CS-SB Y-ADAPTER, MODEL 124 871 | DTD | Substantially Equivalent - Subject to Tracking Reg. | Biotronik, Inc. | accessdata.fda.gov |
| August 14, 1997 | K971930 | BK-N SEALING CAP | DTD | Substantially Equivalent - Subject to Tracking & PMS | Biotronik, Inc. | accessdata.fda.gov |
| July 10, 1997 | K964190 | ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | DTE | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
| April 29, 1997 | K970204 | BK-A; BK-B; BK-IS SEALING CAP | DTD | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 12, 2008 | P070008 | STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD | NKE | 177 | October 22, 2026 | accessdata.fda.gov |
| August 10, 2006 | P050023 | TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD | MRM | 209 | October 22, 2026 | accessdata.fda.gov |
| September 29, 2000 | P000009 | PHYLAX AV ICD SYSTEM | MRM | 128 | October 22, 2026 | accessdata.fda.gov |
| October 27, 1998 | P980023 | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM | LWS | 150 | October 22, 2026 | accessdata.fda.gov |
| October 11, 1996 | P950037 | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS | DXY | 282 | October 22, 2026 | accessdata.fda.gov |
| February 15, 1984 | P820076 | DIPLOS MODEL 05 A & B | LWP | 28 | February 12, 2019 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 8, 2021 | 87549 | Class II | Terminated | BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular ar | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | accessdata.fda.gov |
| June 30, 2015 | 71658 | Class II | Terminated | PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to progra | Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US. | accessdata.fda.gov |
| January 10, 2007 | 46751 | Not yet classified | Terminated | Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; ICS 3000 units are co | Timing Feature Error: An implementation error allows the usage of the V-V timing feature, which is not approved for use in the U.S. | accessdata.fda.gov |
| April 29, 2004 | 28982 | Not yet classified | Terminated | Tachos DR - Implantable Cardioverter Defibrillator | Potential for device to not deliver full amount of energy | accessdata.fda.gov |
| September 24, 2003 | 27418 | Not yet classified | Terminated | Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software. | Potential for early depletion of Implantable Cardioverter Defibrillator battery. | accessdata.fda.gov |
| September 24, 2003 | 27417 | Not yet classified | Terminated | Belos DR Implantable Cardioverter Defibrillator | Potential extended charge time anomalies. | accessdata.fda.gov |
| March 21, 2003 | 26041 | Not yet classified | Terminated | Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmi | Potential extended charge time anomalies | accessdata.fda.gov |
| February 21, 2003 | 25629 | Not yet classified | Terminated | Tachos DR - Implantable Cardioverter Defibrillator. | Potential for battery to delivery less than full amount of energy. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous
- All makers of Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- All makers of Wire, Guide, Catheter
- All makers of Pacemaker Lead Adaptor
- All makers of Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
- All makers of Pacemaker/Icd/Crt Non-Implanted Components
Updated October 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.