510(k) Report

FDA applicant

Wipak OY

Nastola, FI7 decisions2022–20240 recalls

FDA records 7 decisions for Wipak OY (Nastola, FI) from 2022 to 2024: 7 510(k) clearances. All are in product code FRG (Wrap, Sterilization). Since 2016 its 510(k)s took a median of 224 days from receipt to decision, against 217 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Wipak OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 32023: 32024: 1
2022high 3 (2022) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Wipak OY by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wipak OY’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FRGWrap, Sterilization7decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 224 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 217 days; 3 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 4 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K221016Steriking Packaging for Medical DevicesWipak OY · 20221cites it
  • K210810Steiking Packaging for Medical DevicesWipak OY · 20221cites it
  • K221377SteriKing LT-Blueline Pouches with TyvekWipak OY · 20221cites it
  • K221379Steriking LT-Blueline Pouches with TyvekWipak OY · 20231cites it

What has FDA decided for it lately?

  • K232625Steriking® Pouch for Robotic InstrumentsWipak OY · 2024
  • K231999Steriking® LT-Blueline Pouches with Tyvek®Wipak OY · 2023
  • K231996Steriking® LT-Blueline Pouches with Tyvek®Wipak OY · 2023
  • K221379Steriking LT-Blueline Pouches with TyvekWipak OY · 2023
  • K221377SteriKing LT-Blueline Pouches with TyvekWipak OY · 2022
  • K221016Steriking Packaging for Medical DevicesWipak OY · 2022
  • K210810Steiking Packaging for Medical DevicesWipak OY · 2022

All 7 as Wipak OY →