510(k) · Cleared
ClearedAesculap Sterilcontainer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap · FRG Wrap, Sterilization
Cleared on Nov 17, 2006 as substantially equivalent to K792558 (Aesculap Instruments Corp., 1979) and 1 other predicate after an 81-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Nov 17, 2006
- Review
- 81 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K871202 (1987). 7 ancestors in all, the oldest K792558 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 2 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 1 generation backK053389 Aesculap Sterilcontainer SystemAesculap, Inc. · 2006
- This deviceK062510 Aesculap Sterilcontainer SystemAesculap · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −2 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −1 | K053389 | Aesculap Sterilcontainer System | Aesculap, Inc. | 2006 | — |
| 0 (this device) | K062510 | Aesculap Sterilcontainer System | Aesculap | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1997 | 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? (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 |
|---|---|---|---|
| * | K792558 | Container SystemSummary page 1…UBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the SterilcontainerSystem for Ozone Sterilization is substantially equivalent to: Aesculap Sterilcontainer System (K792558) & (K053389) DEVICE DESCRIPTION The Aesculap Sterilcontainer is designed as a container system that will allow for sterilization… | 1979 |
| * | K053389 | Aesculap Sterilcontainer SystemSummary page 1…QUIVALENCE Aesculap®, Inc. believes that the SterilcontainerSystem for Ozone Sterilization is substantially equivalent to: Aesculap Sterilcontainer System (K792558) & (K053389) DEVICE DESCRIPTION The Aesculap Sterilcontainer is designed as a container system that will allow for sterilization and storage… | 2006 |
| † | K020875 | TSO3 Ozone Sterilizer, Model 125L | 2003 |
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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 6 other devices also cite its predicate K792558.
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 System is intended to be used to enclose another medical device(s) that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical devices and also maintain sterility of the enclosed device(s) until used. The Aesculap Sterilcontainer System has been validated for use in an ozone sterilization system (TSO3 125L) to include hinged devices and lumened devices as small as 3mm (diameter) and 550 mm (length).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062510: Aesculap Sterilcontainer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062510
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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