Biotronik Sales, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Biotronik Sales, Inc.” (first 1980, latest 1988), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 65 days. 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 22 | 22 |
| DTB | Permanent Pacemaker Electrode | 15 | 15 |
| DTD | Pacemaker Lead Adaptor | 2 | 2 |
| DTE | Pulse-Generator, Pacemaker, External | 1 | 1 |
| KRG | Programmer, Pacemaker | 1 | 1 |
Review panels
- Cardiovascular (41)
Most recent Biotronik Sales, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K875199 | NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR | DTB | 1988-02-18 | 62 |
| K853194 | ERA-20 | DTE | 1987-03-11 | 589 |
| K860036 | EDP-20 PACEMAKER | DXY | 1987-01-12 | 371 |
| K863879 | NEOS-M VS-1 PULSE GENERATOR | DXY | 1986-12-10 | 65 |
| K863878 | TRIOS-M VS-1 PULSE GENERATOR | DXY | 1986-12-10 | 65 |
| K863480 | BIOTRONIK PERMANENT PACEMAKER ELECTRODE | DTB | 1986-09-23 | 14 |
| K860921 | NEOS VS-1, PULSE GENERATOR | DXY | 1986-08-08 | 150 |
| K860922 | MIKROS, MIKROS VS-1, PULSE GENERATOR | DXY | 1986-08-04 | 146 |
| K853567 | DJP UNIPOLAR | DTB | 1986-05-07 | 254 |
| K853566 | DJ UNIPOLAR | DTB | 1986-05-07 | 254 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biotronik Sales, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Biotronik Sales, Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
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, Inc. (103 510(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 Sales, Inc.?
FDA lists 41 510(k) clearances under the applicant name “Biotronik Sales, Inc.” (first 1980, latest 1988), across 5 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 Sales, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotronik Sales, Inc. is 65 days.
Which FDA product codes appear under Biotronik Sales, Inc.?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 22); DTB (Permanent Pacemaker Electrode, 15); DTD (Pacemaker Lead Adaptor, 2).
Next steps
- See all 41 Biotronik Sales, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXY, Biotronik Sales, 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.