Vitatron Medical BV: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Vitatron Medical BV” (first 1976, latest 1986), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 64 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
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 | 12 | 12 |
| KRG | Programmer, Pacemaker | 3 | 3 |
| DTB | Permanent Pacemaker Electrode | 2 | 2 |
| DTA | Tester, Pacemaker Electrode Function | 1 | 1 |
| DTC | Analyzer, Pacemaker Generator Function | 1 | 1 |
Review panels
- Cardiovascular (19)
Most recent Vitatron Medical BV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854790 | CERYX PACEMAKER MODELS 114, 314 & 614 | DXY | 1986-08-28 | 272 |
| K844484 | HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA | KRG | 1985-07-24 | 247 |
| K844485 | CERYX6, 611, CERYX 3 311 & CERYX 1 111 | KRG | 1985-04-19 | 151 |
| K844483 | TP 1 | KRG | 1985-04-19 | 151 |
| K840668 | ELECTRODE PACEMAKER, PERM & TEMP | DTB | 1984-09-24 | 237 |
| K831860 | GENERATOR, PULSE, PACEMAKER #532 | DXY | 1983-10-27 | 139 |
| K831859 | PACEMAKER PROGRAMMER #2032 | DXY | 1983-10-27 | 139 |
| K810928 | ENDOCARDIAL ELECTRODE | DTB | 1981-07-02 | 87 |
| K791920 | CARDIAC PACEMAKER P4000 SER. & P1000 | DXY | 1979-11-29 | 65 |
| K791921 | CARDIAC PACEMAKER C4000, C1000 SER. | DXY | 1979-10-26 | 31 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vitatron Medical BV.
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 Vitatron Medical BV (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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vitatron Medical BV?
FDA lists 19 510(k) clearances under the applicant name “Vitatron Medical BV” (first 1976, latest 1986), 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 Vitatron Medical BV?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vitatron Medical BV is 64 days.
Which FDA product codes appear under Vitatron Medical BV?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 12); KRG (Programmer, Pacemaker, 3); DTB (Permanent Pacemaker Electrode, 2).
Next steps
- See all 19 Vitatron Medical BV clearances with predicates and recalls
- Run predicate analysis for product code DXY, Vitatron Medical BV'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.