Palodex Group OY: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Palodex Group OY” (first 2012, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 120 days. Since 2017 the median was 105 days, against 118 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 |
|---|---|---|
| 2012 | 1 | 153 |
| 2013 | 1 | 112 |
| 2014 | 1 | 128 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 4 | 112 |
| 2018 | 1 | 57 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 105 |
| 2024 | 1 | 132 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Palodex Group OY took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | 8 | 8 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
Review panels
- Radiology (10)
Most recent Palodex Group OY 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241249 | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | OAS | 2024-09-12 | 132 |
| K230505 | Orthopantomograph OP 3D LX | OAS | 2023-06-09 | 105 |
| K180947 | Orthopantomograph OP 3D | OAS | 2018-06-07 | 57 |
| K173646 | FS Ergo | MUH | 2017-12-19 | 22 |
| K163423 | Orthopantomograph OP300 | OAS | 2017-08-31 | 268 |
| K162799 | Cliniview | LLZ | 2017-04-25 | 202 |
| K170813 | ORTHOPANTOMOGRAPH OP 3D | OAS | 2017-04-07 | 21 |
| K133544 | OP300 | OAS | 2014-03-26 | 128 |
| K130297 | SCANORA 3DX | OAS | 2013-05-29 | 112 |
| K122018 | OP300 | OAS | 2012-12-10 | 153 |
Recalls
5 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2021-10-28.
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 Palodex Group OY?
FDA lists 10 510(k) clearances under the applicant name “Palodex Group OY” (first 2012, latest 2024), across 3 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 Palodex Group OY?
The median time from FDA receipt to decision across 510(k)s cleared under the name Palodex Group OY is 120 days. Since 2017: 105 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Palodex Group OY?
The most frequent FDA product codes under this applicant name are OAS (X-Ray, Tomography, Computed, Dental, 8); LLZ (System, Image Processing, Radiological, 1); MUH (System, X-Ray, Extraoral Source, Digital, 1).
Next steps
- See all 10 Palodex Group OY clearances with predicates and recalls
- Run predicate analysis for product code OAS, Palodex Group OY'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.