Planmed OY: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Planmed OY” (first 1992, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 186 days. Since 2017 the median was 315 days, against 126 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 | 139 |
| 2013 | 1 | 266 |
| 2014 | 0 | — |
| 2015 | 1 | 164 |
| 2016 | 0 | — |
| 2017 | 1 | 395 |
| 2018 | 1 | 235 |
| 2019 | 0 | — |
| 2020 | 1 | 424 |
| 2021 | 0 | — |
| 2022 | 2 | 309 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 234 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Planmed OY took a median 315 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | 11 | 11 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 4 | 4 |
| OAS | X-Ray, Tomography, Computed, Dental | 3 | 3 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| SFV | X-Ray, Computed Tomography, Cone-Beam | 1 | 1 |
Review panels
- Radiology (20)
Most recent Planmed OY 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250318 | Planmed XFI | SFV | 2025-09-26 | 234 |
| K211720 | Planmed Clarity 2D, Planmed Clarify S | MUE | 2022-07-18 | 409 |
| K213278 | Planmed Verity | OAS | 2022-04-28 | 209 |
| K192317 | Planmed Clarity 2D and Clarity S | MUE | 2020-10-23 | 424 |
| K180918 | Planmed Verity | OAS | 2018-11-30 | 235 |
| K163328 | Planmed Clarity | MUE | 2017-12-28 | 395 |
| K143435 | Planmed Verity | OAS | 2015-05-14 | 164 |
| K121418 | PLANMED VERITY | JAK | 2013-02-01 | 266 |
| K121963 | PLANMED NUANCE DIGIGUIDE | MUE | 2012-11-21 | 139 |
| K042671 | PLANMED SOPHIE NUANCE CLASSIC | IZH | 2004-11-19 | 51 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Planmed OY.
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 Planmed OY?
FDA lists 20 510(k) clearances under the applicant name “Planmed OY” (first 1992, latest 2025), 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 Planmed OY?
The median time from FDA receipt to decision across 510(k)s cleared under the name Planmed OY is 186 days. Since 2017: 315 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Planmed OY?
The most frequent FDA product codes under this applicant name are IZH (System, X-Ray, Mammographic, 11); MUE (Full Field Digital, System, X-Ray, Mammographic, 4); OAS (X-Ray, Tomography, Computed, Dental, 3).
Next steps
- See all 20 Planmed OY clearances with predicates and recalls
- Run predicate analysis for product code IZH, Planmed 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.