510(k) · Cleared
ClearedWagner Steriset Sterilization Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wagner GmbH · FRG Wrap, Sterilization
Cleared on Jun 3, 2005 as substantially equivalent to K010825 (Medline, 2001) and 1 other predicate after a 402-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jun 3, 2005
- Review
- 402 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K823902 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK823902 Eagle SterisetAmerican Sterilizer Co. · 1983
- This deviceK041096 Wagner Steriset Sterilization ContainerWagner GmbH · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K823902 | Eagle Steriset | American Sterilizer Co. | 1983 | — |
| 0 (this device) | K041096 | Wagner Steriset Sterilization Container | Wagner GmbH | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K010825 | Medline Steriset Sterilization ContainerSummary page 2…el plated brass. Lid sealing gasket and handle insulation is of silicone rubber. Substantial Equivalence: The containers are identical to the Medline (K010825) and AMSCO (K823902) in design, materials, and intended use. All containers (Medline and AMSCO included) are manufactured by Wagn… | 2001 |
| * | K823902 | Eagle SterisetSummary page 2…sealing gasket and handle insulation is of silicone rubber. Substantial Equivalence: The containers are identical to the Medline (K010825) and AMSCO (K823902) in design, materials, and intended use. All containers (Medline and AMSCO included) are manufactured by Wagner GmBH.. Biocompat… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K010825.
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The SteriSet Sterilizatoin Conatiner is intended to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to be used to allow sterilization of the enclosed medical device and also to maintain sterility until used. The SterieSet Containers are designed for use with high-vacuum or pulse-vacuum steam sterilization systems. They are not suitable for gravity, gravity flash, or ethylene oxide (EO) gas cycles due to their "closed design".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041096 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041096: Wagner Steriset Sterilization Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041096
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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