510(k) · Cleared
ClearedAesculap Sterrad 100S Compatable Sterilcontainer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap · FRG Wrap, Sterilization
Cleared on Dec 6, 2004 after a 248-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Dec 6, 2004
- Review
- 248 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK040865 Aesculap Sterrad 100S Compatable SterilcontainerAesculap · 2004
- Descendant · cites it directly · 4 of its ownK093493 Aesculap Sterilcontainer SAesculap, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK093649 Aesculap Sterilcontainer SAesculap · 2010
- Descendant · 2 generations on · 2 of its ownK151242 SterilContainer SAesculap, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK162815 SterilContainer S SystemAesculap, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK110682 Steritite Container System & Meditray ProductsCase Medical, Inc. · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K093493Aesculap Sterilcontainer SAesculap, Inc. · 2010 · cites it directly4descendants
- K093649Aesculap Sterilcontainer SAesculap · 2010 · cites it directly4descendants
- K151242SterilContainer SAesculap, Inc. · 2015 · 2 generations on2descendants
- K162815SterilContainer S SystemAesculap, Inc. · 2017 · 3 generations on1descendant
- K110682Steritite Container System & Meditray ProductsCase Medical, Inc. · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040865 | Aesculap Sterrad 100S Compatable Sterilcontainer | Aesculap | 2004 | — |
| +1 | K093493 | Aesculap Sterilcontainer S | Aesculap, Inc. | 2010 | — |
| +1 | K093649 | Aesculap Sterilcontainer S | Aesculap | 2010 | — |
| +2 | K151242 | SterilContainer S | Aesculap, Inc. | 2015 | — |
| +3 | K162815 | SterilContainer S System | Aesculap, Inc. | 2017 | — |
| +2 | K110682 | Steritite Container System & Meditray Products | Case Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | — | Aesculap Sterilcontainers Named without a submission number | |
| * | — | Allegiance Healthcare (Genesis) sterilization containers Named without a submission number | |
| * | — | Case Medical (SteriTite) sterilization containers Named without a submission number |
What descends from it? (10)
2 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, K093493 (Aesculap, Inc., 2010) has gone furthest, with 4 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 | — |
What is it indicated for?
The Aesculap Sterilcontainer is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the Sterrad 100S.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040865 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040865: Aesculap Sterrad 100S Compatable Sterilcontainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040865
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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