510(k) · Cleared
ClearedAesculap Sterilcontainer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · FRG Wrap, Sterilization
Cleared on Feb 15, 2006 as substantially equivalent to K022978 (Case Medical, Inc., 2003) and 2 other predicates after a 72-day review. Its family tree reaches back 2 generations to 1987. 12 later devices descend from it.
- Decided
- Feb 15, 2006
- Review
- 72 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K871202 (1987). 6 ancestors in all, the oldest K792558 (1979). 12 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 1 generation backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- This deviceK053389 Aesculap Sterilcontainer SystemAesculap, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK073168 Aesculap Primeline Container LTD.Aesculap, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK112671 Sterilcontainer SystemAesculap, Ltd. · 2012
- Descendant · 2 generations on · 5 of its ownK192056 JJ Series Container SystemAesculap, Inc. · 2020
- Descendant · 3 generations on · 4 of its ownK214041 Aesculap AICON ContainerAesculap, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK131407 Bahadir Sterilization TraysBahadir USA Corp. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K073168Aesculap Primeline Container LTD.Aesculap, Inc. · 2008 · cites it directly9descendants
- K112671Sterilcontainer SystemAesculap, Ltd. · 2012 · cites it directly7descendants
- K192056JJ Series Container SystemAesculap, Inc. · 2020 · 2 generations on5descendants
- K214041Aesculap AICON ContainerAesculap, Inc. · 2022 · 3 generations on4descendants
- K131407Bahadir Sterilization TraysBahadir USA Corp. · 2014 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −1 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| 0 (this device) | K053389 | Aesculap Sterilcontainer System | Aesculap, Inc. | 2006 | — |
| +1 | K073168 | Aesculap Primeline Container LTD. | Aesculap, Inc. | 2008 | — |
| +1 | K112671 | Sterilcontainer System | Aesculap, Ltd. | 2012 | — |
| +2 | K192056 | JJ Series Container System | Aesculap, Inc. | 2020 | — |
| +3 | K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022 | — |
| +1 | K131407 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1997 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsSummary page 1…Aesculap,, Inc. believes that the SterilcontainerSystem for Flash Sterilization is substantially equivalent to: Case Medical Steritite Container with Flashtite Valve (K022978) Riley Medical Flashpak Container System (K871202) Aesculap Sterilcontainer System (K792558) DEVICE DESCRIPTION The Flash compat… | 2003 |
| * | K871202 | Flashpak Container SystemSummary page 1…rSystem for Flash Sterilization is substantially equivalent to: Case Medical Steritite Container with Flashtite Valve (K022978) Riley Medical Flashpak Container System (K871202) Aesculap Sterilcontainer System (K792558) DEVICE DESCRIPTION The Flash compatible Aesculap Sterilcontainer is designed as a con… | 1987 |
| * | K792558 | Container SystemSummary page 1…tially equivalent to: Case Medical Steritite Container with Flashtite Valve (K022978) Riley Medical Flashpak Container System (K871202) Aesculap Sterilcontainer System (K792558) DEVICE DESCRIPTION The Flash compatible Aesculap Sterilcontainer is designed as a container system that will allow for steriliz… | 1979 |
What descends from it? (12)
See all 124 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K073168 (Aesculap, Inc., 2008) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K022978.
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 (consisting of a solid bottom, a perforated lid w/ filter retention plates, and disposable paper filters) 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 has been validated with stainless…
Read the full statement (167 words)
The Aesculap Sterilcontainer is a reusable sterilization container system (consisting of a solid bottom, a perforated lid w/ filter retention plates, and disposable paper filters) 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 has been validated with stainless steel lumens, hinged, and knurled instruments (stainless steel lumens of greater than 3 mm inner diameter or less than 400 mm in length). This container system is compatible for use in pre-vacuum (steam) flash sterilization. The SterilContainer System for includes accessories such as baskets, trays, and racks.
The following containers (lids & bottoms) were validated for pre-vacuum Flash sterilization:
Full Size: Lid JK489/ Bottoms JK440, JK441, JK442, and JK444
Three-Quarter Size: Lid JK789/ Bottoms JK740, JK741, and JK742
Half Size: Lid JK389/ Bottoms JK339, JK340, JK341, JK342, and JK344
Mini Containers: Lid JK174/ Bottoms JK187 and JK188
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053389: Aesculap Sterilcontainer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053389
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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