Vitromed GmbH: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Vitromed GmbH” (first 2020, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 247 days. Since 2017 the median was 247 days, against 204 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 |
|---|---|---|
| 2020 | 2 | 266 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 195 |
| 2024 | 2 | 240 |
| 2025 | 1 | 269 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vitromed GmbH took a median 247 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 204 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQL | Media, Reproductive | 6 | 6 |
| MQH | Microtools, Assisted Reproduction (Pipettes) | 1 | 1 |
Review panels
Most recent Vitromed GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241833 | V-GRAD | MQL | 2025-03-21 | 269 |
| K240176 | V-VITFREEZE and V-VITWARM | MQL | 2024-09-13 | 234 |
| K232125 | V-PVP | MQL | 2024-03-20 | 247 |
| K222606 | V-HYADASE | MQL | 2023-05-26 | 270 |
| K223117 | V-SPERM WASH | MQL | 2023-01-31 | 120 |
| K193285 | V-ONESTEP | MQL | 2020-11-20 | 359 |
| K192146 | V-DENUPET | MQH | 2020-01-28 | 173 |
Recalls
openFDA lists no recalls under a recalling firm named Vitromed GmbH.
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.
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.
- Vitromed Langenfeld (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vitromed GmbH?
FDA lists 7 510(k) clearances under the applicant name “Vitromed GmbH” (first 2020, latest 2025), across 2 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 Vitromed GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vitromed GmbH is 247 days. Since 2017: 247 days, versus 204 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vitromed GmbH?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 6); MQH (Microtools, Assisted Reproduction (Pipettes), 1).
Next steps
- See all 7 Vitromed GmbH clearances with predicates and recalls
- Run predicate analysis for product code MQL, Vitromed GmbH'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.