510(k) · Cleared
ClearedContainer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Instruments Corp. · FLE Sterilizer, Steam
Cleared on Dec 27, 1979 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Dec 27, 1979
- Review
- 15 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 7 citing it directly.
- This deviceK792558 Container SystemAesculap Instruments Corp. · 1979
- Descendant · cites it directly · 12 of its ownK053389 Aesculap Sterilcontainer SystemAesculap, Inc. · 2006
- Descendant · cites it directly · 10 of its ownK041623 Reusable Sterilcontainer Filter Model #JK090Aesculap, Inc. · 2004
- 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
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K053389Aesculap Sterilcontainer SystemAesculap, Inc. · 2006 · cites it directly12descendants
- K041623Reusable Sterilcontainer Filter Model #JK090Aesculap, Inc. · 2004 · cites it directly10descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K792558 | Container System | Aesculap Instruments Corp. | 1979 | — |
| +1 | K053389 | Aesculap Sterilcontainer System | Aesculap, Inc. | 2006 | — |
| +1 | K041623 | Reusable Sterilcontainer Filter Model #JK090 | Aesculap, Inc. | 2004 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 FLE? 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 FLE device
- #1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 167 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053389 | Aesculap Sterilcontainer System | 2006 | 12 |
| K041623 | Reusable Sterilcontainer Filter Model #JK090 | 2004 | 10 |
| K073168 | Aesculap Primeline Container LTD. | 2008 | 9 |
| K112671 | Sterilcontainer System | 2012 | 7 |
| K182414 | Aesculap® SterilContainer (TM) S2 System | 2019 | 1 |
| K062510 | Aesculap Sterilcontainer System | 2006 | 0 |
| K972138 | Carr Rigid Container System | 1997 | 0 |
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, K053389 (Aesculap, Inc., 2006) has gone furthest, with 12 descendants of its own.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLE
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLE
71in 2025
MAUDE reports naming product code FLE, 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 | 5 | 67 | 1 | 19 |
| 2008 | 1 | — | 1 | 21 |
| 2009 | 8 | 109 | 0 | 19 |
| 2010 | 2 | — | 0 | 20 |
| 2011 | 5 | 141 | 1 | 63 |
| 2012 | 5 | 111 | 1 | 69 |
| 2013 | 5 | 241 | 2 | 112 |
| 2014 | 2 | — | 0 | 113 |
| 2015 | 3 | 302 | 1 | 68 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 3 | 233 | 0 | 63 |
| 2018 | 8 | 146 | 1 | 90 |
| 2019 | 5 | 192 | 2 | 91 |
| 2020 | 2 | — | 0 | 87 |
| 2021 | 5 | 147 | 1 | 81 |
| 2022 | 10 | 133 | 0 | 70 |
| 2023 | 7 | 88 | 0 | 66 |
| 2024 | 2 | — | 0 | 64 |
| 2025 | 4 | 184 | 0 | 71 |
| 2026 | 3 | 85 | 1 | — |
https://510kreport.com/device/K792558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K792558: Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K792558
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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