# Wipak OY

- Location (FDA's records): Nastola, FI
- FDA decisions: 7 (2022–2024): 7 510(k) clearances
- Product codes: FRG (7)
- 510(k) review time since 2016: median 224 days, against 217 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sigma Medical Supplies Corp.: 2 (https://510kreport.com/company/sigma-medical-supplies)
- Wihuri OY: 1 (https://510kreport.com/company/wihuri)

## Its most-cited devices
- K221016: Steriking Packaging for Medical Devices (2022), cited by 1
- K210810: Steiking Packaging for Medical Devices (2022), cited by 1
- K221377: SteriKing LT-Blueline Pouches with Tyvek (2022), cited by 1
- K221379: Steriking LT-Blueline Pouches with Tyvek (2023), cited by 1

## Recent decisions
- K232625: Steriking® Pouch for Robotic Instruments (Jun 7, 2024)
- K231999: Steriking® LT-Blueline Pouches with Tyvek® (Sep 7, 2023)
- K231996: Steriking® LT-Blueline Pouches with Tyvek® (Sep 7, 2023)
- K221379: Steriking LT-Blueline Pouches with Tyvek (Jan 4, 2023)
- K221377: SteriKing LT-Blueline Pouches with Tyvek (Dec 22, 2022)
- K221016: Steriking Packaging for Medical Devices (May 5, 2022)
- K210810: Steiking Packaging for Medical Devices (Jan 23, 2022)

Source page: https://510kreport.com/company/wipak