Wipak OY: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Wipak OY” (first 2022, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 224 days. Since 2017 the median was 224 days, against 226 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 | 3 | 224 |
| 2023 | 3 | 64 |
| 2024 | 1 | 283 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wipak OY took a median 224 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 226 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRG | Wrap, Sterilization | 7 | 7 |
Review panels
- General Hospital (7)
Most recent Wipak OY 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232625 | Steriking® Pouch for Robotic Instruments | FRG | 2024-06-07 | 283 |
| K231999 | Steriking® LT-Blueline Pouches with Tyvek® | FRG | 2023-09-07 | 64 |
| K231996 | Steriking® LT-Blueline Pouches with Tyvek® | FRG | 2023-09-07 | 64 |
| K221379 | Steriking LT-Blueline Pouches with Tyvek | FRG | 2023-01-04 | 237 |
| K221377 | SteriKing LT-Blueline Pouches with Tyvek | FRG | 2022-12-22 | 224 |
| K221016 | Steriking Packaging for Medical Devices | FRG | 2022-05-05 | 30 |
| K210810 | Steiking Packaging for Medical Devices | FRG | 2022-01-23 | 312 |
Recalls
openFDA lists no recalls under a recalling firm named Wipak 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 Wipak OY?
FDA lists 7 510(k) clearances under the applicant name “Wipak OY” (first 2022, latest 2024), across 1 product code 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 Wipak OY?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wipak OY is 224 days. Since 2017: 224 days, versus 226 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wipak OY?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 7).
Next steps
- See all 7 Wipak OY clearances with predicates and recalls
- Run predicate analysis for product code FRG, Wipak 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.