Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Wipak OY — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

224 daysmedian FDA review time
312 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232625Steriking® Pouch for Robotic InstrumentsWipak OY2024-06-072830
K231999Steriking® LT-Blueline Pouches with Tyvek®Wipak OY2023-09-07640
K231996Steriking® LT-Blueline Pouches with Tyvek®Wipak OY2023-09-07640
K221379Steriking LT-Blueline Pouches with TyvekWipak OY2023-01-042370
K221377SteriKing LT-Blueline Pouches with TyvekWipak OY2022-12-222240
K221016Steriking Packaging for Medical DevicesWipak OY2022-05-05300
K210810Steiking Packaging for Medical DevicesWipak OY2022-01-233120

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda