Feops NV: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Feops NV” (first 2022, latest 2025), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 165 days. Since 2017 the median was 165 days, against 140 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 |
|---|---|---|
| 2022 | 1 | 60 |
| 2023 | 1 | 165 |
| 2024 | 0 | — |
| 2025 | 1 | 267 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Feops NV took a median 165 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QQI | Interventional Cardiovascular Implant Simulation Software Device | 3 | 2 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Cardiovascular (3)
- Radiology (1)
Most recent Feops NV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250635 | FEops HEARTguide Simulation Application | QQI | 2025-11-25 | 267 |
| K223855 | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | QIH | 2023-06-06 | 165 |
| K214066 | FEops HEARTguide | QQI | 2022-02-25 | 60 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200030 | De Novo | Interventional Cardiovascular Implant Simulation Software Device | 2021-09-08 |
Recalls
openFDA lists no recalls under a recalling firm named Feops NV.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Feops NV?
FDA lists 3 510(k) clearances under the applicant name “Feops NV” (first 2022, latest 2025), plus 1 De Novo decision, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Feops NV?
The median time from FDA receipt to decision across 510(k)s cleared under the name Feops NV is 165 days. Since 2017: 165 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Feops NV?
The most frequent FDA product codes under this applicant name are QQI (Interventional Cardiovascular Implant Simulation Software Device, 3); QIH (Automated Radiological Image Processing Software, 1).
Next steps
- See all 3 Feops NV clearances with predicates and recalls
- Run predicate analysis for product code QQI, Feops NV'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.