Orfit Industries NV: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Orfit Industries NV” (first 2013, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 64 days. Since 2017 the median was 54 days, against 112 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 |
|---|---|---|
| 2013 | 1 | 100 |
| 2014 | 1 | 36 |
| 2015 | 1 | 83 |
| 2016 | 2 | 60 |
| 2017 | 1 | 43 |
| 2018 | 0 | — |
| 2019 | 1 | 97 |
| 2020 | 2 | 41 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orfit Industries NV took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 8 | 8 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 1 | 1 |
Review panels
- Radiology (9)
Most recent Orfit Industries NV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202068 | The AIO Solution 3.0 | IYE | 2020-08-14 | 18 |
| K200282 | Orfit Aerial Couchtop | LHN | 2020-04-08 | 64 |
| K191158 | The AIO Solution | IYE | 2019-08-06 | 97 |
| K171734 | HP PRO Positioning Device | IYE | 2017-07-25 | 43 |
| K162355 | Raycast MammoRx Carbon Fibre Breast Board | IYE | 2016-11-22 | 91 |
| K162862 | Raycast High Precision Lung Board Solution | IYE | 2016-11-09 | 28 |
| K151207 | Proton Immobilization Solution | IYE | 2015-07-28 | 83 |
| K141787 | SAGITTILT | IYE | 2014-08-07 | 36 |
| K131795 | NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS | IYE | 2013-09-26 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Orfit Industries 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.
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.
- Orfit Industries (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orfit Industries NV?
FDA lists 9 510(k) clearances under the applicant name “Orfit Industries NV” (first 2013, latest 2020), 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 Orfit Industries NV?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orfit Industries NV is 64 days. Since 2017: 54 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orfit Industries NV?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 8); LHN (System, Radiation Therapy, Charged-Particle, Medical, 1).
Next steps
- See all 9 Orfit Industries NV clearances with predicates and recalls
- Run predicate analysis for product code IYE, Orfit Industries 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 (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.