# Biotronik, Inc.

- Location (FDA's records): Lake Oswego, OR
- FDA decisions: 115 (1984–2026): 104 510(k) clearances and 11 original PMA approvals
- Names in FDA's records: Biotronik, Inc. (92); Biotronik, GmbH & Co. (18); Biotronik AG (4); Biotronik GmbH & Co. KG (1)
- Product codes: DTB (26), DQY (23), MXD (11), DXY (10), LIT (10), DTD (6), DQX (5), DTA (3), LOX (3), MRM (2), MAF (2), DTE (2)
- 510(k) review time since 2016: median 59 days, against 111 for FDA's reviews in the same codes and years (10 of 19 faster)
- Predicates its devices cite: 111 (87 its own); citations of its devices by later devices: 94 (87 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- St Jude Medical: 3 (https://510kreport.com/company/st-jude-medical)
- Guidant Corp.: 3 (https://510kreport.com/company/guidant)
- Medtronic Vascular: 3 (https://510kreport.com/company/medtronic-vascular)
- Medtronic, Inc.: 2 (https://510kreport.com/company/medtronic)
- Medtronic, Ireland: 2 (https://510kreport.com/company/medtronic-ireland)
- Jomed, Inc.: 2 (https://510kreport.com/company/jomed)
- Medtronic Cardiorhythm: 1 (https://510kreport.com/company/medtronic-cardiorhythm)
- Cordis Webster, Inc.: 1 (https://510kreport.com/company/cordis-webster)

## Firms that cite its devices most
- Concert Medical, LLC: 2 (https://510kreport.com/company/concert-medical)
- Thomas Medical Products, Inc.: 1 (https://510kreport.com/company/thomas-medical-products)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Remington Medical, Inc.: 1 (https://510kreport.com/company/remington-medical)
- Osypka Medical, Inc.: 1 (https://510kreport.com/company/osypka-medical)
- St Jude Medical, Crmd: 1 (https://510kreport.com/company/st-jude-medical-crmd)

## Its most-cited devices
- K964190: Era 300 Dual Chamber Pacing System Analyzer (1997), cited by 5
- K060807: Scoutpro 7F Coronary Sinus Lead Delivery System (2006), cited by 5
- K022360: Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000 Battery (Type 2); NK-11 Power Supp. (2003), cited by 3
- K101776: Scoutpro Acs (2010), cited by 3
- K980869: Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and 120 143 (1998), cited by 3
- K152995: BioMonitor 2-AF, BioMonitor 2-S (2016), cited by 3

## Recent decisions
- K261074: Biomonitor IV (471155) (May 1, 2026)
- 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 (Apr 4, 2025)
- K242969: Pantera Pro; Pantera LEO (Oct 25, 2024)
- K240787: Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) (Sep 12, 2024)
- K241711: Oscar Peripheral Multifunctional Catheter system (Jul 11, 2024)
- K230375: Biomonitor IV (May 19, 2023)
- K222065: Passeo-35 Xeo Peripheral Dilatation Catheter (Feb 16, 2023)
- K221856: BIOMONITOR IIIm, BIOMONITOR III (Jul 27, 2022)

Source page: https://510kreport.com/company/biotronik