Biotronik, Inc.: FDA filings under this applicant name
FDA lists 103 510(k) clearances under the applicant name “Biotronik, Inc.” (first 1989, latest 2026), plus 6 PMA decisions, across 19 product codes in 1 review panel. Median 510(k) review time under this name: 79 days. Since 2017 the median was 36 days, against 120 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 77 |
| 2014 | 2 | 180 |
| 2015 | 4 | 86 |
| 2016 | 2 | 182 |
| 2017 | 3 | 30 |
| 2018 | 1 | 20 |
| 2019 | 3 | 59 |
| 2020 | 3 | 155 |
| 2021 | 1 | 458 |
| 2022 | 3 | 30 |
| 2023 | 2 | 156 |
| 2024 | 3 | 29 |
| 2025 | 1 | 25 |
| 2026 | 1 | 30 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biotronik, Inc. took a median 36 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 26 | 26 |
| DQY | Catheter, Percutaneous | 23 | 23 |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | 11 | 11 |
| DXY | Implantable Pacemaker Pulse-Generator | 10 | 9 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 9 | 9 |
| DTD | Pacemaker Lead Adaptor | 6 | 6 |
| DQX | Wire, Guide, Catheter | 5 | 5 |
| DTA | Tester, Pacemaker Electrode Function | 3 | 3 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 3 | 3 |
| DTC | Analyzer, Pacemaker Generator Function | 2 | 2 |
Plus 9 more product codes.
Review panels
- Cardiovascular (109)
Most recent Biotronik, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261074 | BIOMONITOR IV (471155) | MXD | 2026-05-01 | 30 |
| 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 | 2025-04-04 | 25 |
| K242969 | Pantera Pro; Pantera LEO | LOX | 2024-10-25 | 29 |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | DQY | 2024-09-12 | 174 |
| K241711 | Oscar Peripheral Multifunctional Catheter system | LIT | 2024-07-11 | 27 |
| K230375 | BIOMONITOR IV | MXD | 2023-05-19 | 95 |
| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | LIT | 2023-02-16 | 218 |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | MXD | 2022-07-27 | 30 |
| K222037 | Selectra Lead Implantation System | DQY | 2022-07-19 | 8 |
| K214038 | Oscar Peripheral Multifunctional Catheter system | LIT | 2022-07-06 | 195 |
93 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P070008 | PMA | STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD | 2008-05-12 |
| P050023 | PMA | TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD | 2006-08-10 |
| P000009 | PMA | PHYLAX AV ICD SYSTEM | 2000-09-29 |
| P980023 | PMA | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM | 1998-10-27 |
| P950037 | PMA | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS | 1996-10-11 |
Recalls
42 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2021-03-08.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Biotronik, Inc. is the lead sponsor of 23 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07118358: BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System (Recruiting, started 2026-03-16)
- NCT06540079: BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S (Active not recruiting, started 2024-12-18)
- NCT05251363: BIOTRONIK Conduction System Pacing With the Solia Lead (Completed, started 2022-12-12)
- NCT04683718: A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System with HomeStream Remote Management (Active not recruiting, started 2021-09-20)
- NCT04175626: Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions (Completed, started 2020-01-24)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Biotronik, Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via LWP)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biotronik Sales, Inc. (41 510(k)s)
- Biotronik Cardiac Pacemakers (3 510(k)s)
- Biotronik AG (1 510(k)s)
- Biotronik GmbH & Co. KG (0 510(k)s)
- Biotronik Nro, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biotronik, Inc.?
FDA lists 103 510(k) clearances under the applicant name “Biotronik, Inc.” (first 1989, latest 2026), plus 6 PMA decisions, across 19 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biotronik, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotronik, Inc. is 79 days. Since 2017: 36 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biotronik, Inc.?
The most frequent FDA product codes under this applicant name are DTB (Permanent Pacemaker Electrode, 26); DQY (Catheter, Percutaneous, 23); MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection), 11).
Next steps
- See all 103 Biotronik, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTB, Biotronik, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.