510(k) · Cleared
ClearedSteriking Packaging for Medical Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wipak OY · FRG Wrap, Sterilization
Cleared on May 5, 2022 as substantially equivalent to K210810 (Wipak OY, 2022) after a 30-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- May 5, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953776 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK953776 Steriking Sterilization Pouches & RollsWihuri OY · 1995
- 1 generation backK210810 Steiking Packaging for Medical DevicesWipak OY · 2022
- This deviceK221016 Steriking Packaging for Medical DevicesWipak OY · 2022
- Descendant · cites it directly · 0 of its ownK232625 Steriking® Pouch for Robotic InstrumentsWipak OY · 2024
Most influential descendants
Showing 1 of 1 · See all- K232625Steriking® Pouch for Robotic InstrumentsWipak OY · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953776 | Steriking Sterilization Pouches & Rolls | Wihuri OY | 1995 | — |
| −1 | K210810 | Steiking Packaging for Medical Devices | Wipak OY | 2022 | — |
| 0 (this device) | K221016 | Steriking Packaging for Medical Devices | Wipak OY | 2022 | — |
| +1 | K232625 | Steriking® Pouch for Robotic Instruments | Wipak OY | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRG device
- #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210810 | Steiking Packaging for Medical DevicesSummary page 4…usual name, and the Regulation number (21 CFR 880.6850) classification Product code (FRG) name a3 Identification of the legally K210810, Steriking Packaging for Medical Devices marketed device to which the submitter claims equivalence (predicate… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232625 | Steriking® Pouch for Robotic Instruments | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 26.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K232625 (Wipak OY, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FRG
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRG
151in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRG
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRG
18in 2025
MAUDE reports naming product code FRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 182 | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 4 | 171 | 0 | 2 |
| 2010 | 4 | 213 | 0 | 0 |
| 2011 | 6 | 110 | 0 | 12 |
| 2012 | 10 | 133 | 0 | 4 |
| 2013 | 6 | 146 | 2 | 5 |
| 2014 | 8 | 177 | 0 | 13 |
| 2015 | 12 | 196 | 0 | 9 |
| 2016 | 9 | 131 | 0 | 20 |
| 2017 | 9 | 260 | 29 | 7 |
| 2018 | 5 | 150 | 0 | 22 |
| 2019 | 9 | 258 | 0 | 10 |
| 2020 | 5 | 122 | 14 | 21 |
| 2021 | 4 | 170 | 0 | 9 |
| 2022 | 9 | 217 | 2 | 4 |
| 2023 | 9 | 230 | 0 | 13 |
| 2024 | 11 | 182 | 0 | 21 |
| 2025 | 9 | 151 | 0 | 18 |
| 2026 | 4 | 247 | 0 | — |
What is it indicated for?
Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 135oC for 3 minutes; Drying time of 16 minutes…
Read the full statement (258 words)
Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows:
Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes
Pre-vacuum steam at 135oC for 3 minutes; Drying time of 16 minutes
The Steriking Packaging for medical devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be selfsealed once a device is inserted. Self-sealable pouches are featured with adhesive strip allowing tight, impermeable closing of a pack. The closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded along the pre-folded line. Flap should be pressed firmly against the laminate from the center working outwards to ensure a good, even seal.
Steriking Packaging for Medical Devices maintains the sterility of the enclosed devices for up to 12 months post Steam sterilization and before sterilization has a maximum shelflife of 5 years from the date of manufacture.
Steriking Packaging for Medical Devices Dimensional configurations (2 sizes 200mm x 800mm, 250mm x 875mm)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221016: Steriking Packaging for Medical Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221016
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026