510(k) · Cleared
ClearedMedline Steriset Sterilization Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline · FRG Wrap, Sterilization
Cleared on May 8, 2001 after a 50-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- May 8, 2001
- Review
- 50 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK010825 Medline Steriset Sterilization ContainerMedline · 2001
- Descendant · cites it directly · 10 of its ownK041623 Reusable Sterilcontainer Filter Model #JK090Aesculap, Inc. · 2004
- Descendant · 2 generations on · 9 of its ownK073168 Aesculap Primeline Container LTD.Aesculap, Inc. · 2008
- Descendant · 3 generations on · 7 of its ownK112671 Sterilcontainer SystemAesculap, Ltd. · 2012
- Descendant · 4 generations on · 5 of its ownK192056 JJ Series Container SystemAesculap, Inc. · 2020
- Descendant · 5 generations on · 4 of its ownK214041 Aesculap AICON ContainerAesculap, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K041623Reusable Sterilcontainer Filter Model #JK090Aesculap, Inc. · 2004 · cites it directly10descendants
- K073168Aesculap Primeline Container LTD.Aesculap, Inc. · 2008 · 2 generations on9descendants
- K112671Sterilcontainer SystemAesculap, Ltd. · 2012 · 3 generations on7descendants
- K192056JJ Series Container SystemAesculap, Inc. · 2020 · 4 generations on5descendants
- K214041Aesculap AICON ContainerAesculap, Inc. · 2022 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010825 | Medline Steriset Sterilization Container | Medline | 2001 | — |
| +1 | K041623 | Reusable Sterilcontainer Filter Model #JK090 | Aesculap, Inc. | 2004 | — |
| +2 | K073168 | Aesculap Primeline Container LTD. | Aesculap, Inc. | 2008 | — |
| +3 | K112671 | Sterilcontainer System | Aesculap, Ltd. | 2012 | — |
| +4 | K192056 | JJ Series Container System | Aesculap, Inc. | 2020 | — |
| +5 | K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K041623 (Aesculap, Inc., 2004) has gone furthest, with 10 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.
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 | — |
https://510kreport.com/device/K010825 · printed Nov 5, 2026
Cite this page
510(k) Report. “K010825: Medline 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/K010825
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026