510(k) · Cleared
ClearedAesculap Sterilcontainer S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · FRG Wrap, Sterilization
Cleared on Jul 27, 2010 as substantially equivalent to K040865 (Aesculap, 2004) and 1 other predicate after a 259-day review. Its family tree reaches back 1 generation to 2004. 4 later devices descend from it.
- Decided
- Jul 27, 2010
- Review
- 259 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K040865 (2004). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK040865 Aesculap Sterrad 100S Compatable SterilcontainerAesculap · 2004
- This deviceK093493 Aesculap Sterilcontainer SAesculap, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK110682 Steritite Container System & Meditray ProductsCase Medical, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK182032 SterilContainer S SystemAesculap, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK161415 SteriTite Containers System & MediTray ProductsCase Medical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK142970 SterilContainer S SystemAesculap, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K110682Steritite Container System & Meditray ProductsCase Medical, Inc. · 2011 · cites it directly1descendant
- K182032SterilContainer S SystemAesculap, Inc. · 2018 · cites it directly0descendants
- K161415SteriTite Containers System & MediTray ProductsCase Medical, Inc. · 2017 · 2 generations on0descendants
- K142970SterilContainer S SystemAesculap, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040865 | Aesculap Sterrad 100S Compatable Sterilcontainer | Aesculap | 2004 | — |
| 0 (this device) | K093493 | Aesculap Sterilcontainer S | Aesculap, Inc. | 2010 | — |
| +1 | K110682 | Steritite Container System & Meditray Products | Case Medical, Inc. | 2011 | — |
| +1 | K182032 | SterilContainer S System | Aesculap, Inc. | 2018 | — |
| +2 | K161415 | SteriTite Containers System & MediTray Products | Case Medical, Inc. | 2017 | — |
| +1 | K142970 | SterilContainer S System | Aesculap, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K040865 | Aesculap Sterrad 100S Compatable SterilcontainerSummary page 1…G SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the SterilContainer S is substantially equivalent to: * Aesculap STERRAD 1005SCompatible Sterilcontainer (K040865). * SteriTite Universal Container System with MediTray Products fbrSTERRAD 200, STERRAID NX, Ozone 125L, Sterili… | 2004 |
| * | K080558 | Steritite Container System & Meditray ProductsSummary page 1…Tite Universal Container System with MediTray Products fbrSTERRAD 200, STERRAID NX, Ozone 125L, Sterilization, and Prevacuum Steam Flash Sterilization (K080558). DEVICE DESCRIPTION The Aesculap Sterilcontainer S is designed as a container system that will all ow for sterilization and sto… | 2008 |
What descends from it? (4)
3 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?
How does its category compare?
All FRG devicesFRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Aesculap Sterilcontainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and disposable polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container has been validated with stainless steel lumens, hinged, and knurled instruments. It is intended to allow sterilization of the enclosed…
Read the full statement (217 words)
The Aesculap Sterilcontainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and disposable polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container has been validated with stainless steel lumens, hinged, and knurled instruments. 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 200, STERRAD NX (Standard cycle and Advanced cycle), and STERRAD 100ONX (Standard cycle and Flex cycle). The Sterilcontainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
The Steriicontainer S is recommended for surface and lumens:
STERRAD 200, stainless steel lumens Ž:3mm I.D. x!•400mm L
STERRAD NX standard cycle, stainless steel lumens Ž 2mm I.D. x S400mm L
STERRAD NX advanced cycle, stainless steel lumens Ž 1mm l.D. x S 500mm L
STERRADI1 ONX standard cycle, stainless steel lumens Ž0.7mm l.D. x 5500mm L
STERRAD 1 ONX flex cycle, porous lumens (flexible endoscope) Žlmm1.0. x S850mm L
30 days of shelf life testing has been conducted for the Sterilicontainer S.
The attached tables identify which products may be sterilized in which STERRAD sterilization cycle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093493 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093493: Aesculap Sterilcontainer S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093493
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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