510(k) · Cleared
ClearedReusable Sterilcontainer Filter Model #JK090
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · FRG Wrap, Sterilization
Cleared on Dec 13, 2004 as substantially equivalent to K792558 (Aesculap Instruments Corp., 1979) and 2 other predicates after a 180-day review. Its family tree reaches back 1 generation to 1979. 10 later devices descend from it.
- Decided
- Dec 13, 2004
- Review
- 180 days
- Class
- Class II
- Product code
- FRG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K792558 (1979). 3 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK792558 Container SystemAesculap Instruments Corp. · 1979
- This deviceK041623 Reusable Sterilcontainer Filter Model #JK090Aesculap, Inc. · 2004
- Descendant · cites it directly · 9 of its ownK073168 Aesculap Primeline Container LTD.Aesculap, Inc. · 2008
- Descendant · 2 generations on · 7 of its ownK112671 Sterilcontainer SystemAesculap, Ltd. · 2012
- Descendant · 3 generations on · 5 of its ownK192056 JJ Series Container SystemAesculap, Inc. · 2020
- Descendant · 4 generations on · 4 of its ownK214041 Aesculap AICON ContainerAesculap, Inc. · 2022
- Descendant · 5 generations on · 0 of its ownK242762 Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K073168Aesculap Primeline Container LTD.Aesculap, Inc. · 2008 · cites it directly9descendants
- K112671Sterilcontainer SystemAesculap, Ltd. · 2012 · 2 generations on7descendants
- K192056JJ Series Container SystemAesculap, Inc. · 2020 · 3 generations on5descendants
- K214041Aesculap AICON ContainerAesculap, Inc. · 2022 · 4 generations on4descendants
- K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792558 | Container System | Aesculap Instruments Corp. | 1979 | — |
| 0 (this device) | K041623 | Reusable Sterilcontainer Filter Model #JK090 | Aesculap, Inc. | 2004 | — |
| +1 | K073168 | Aesculap Primeline Container LTD. | Aesculap, Inc. | 2008 | — |
| +2 | K112671 | Sterilcontainer System | Aesculap, Ltd. | 2012 | — |
| +3 | K192056 | JJ Series Container System | Aesculap, Inc. | 2020 | — |
| +4 | K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022 | — |
| +5 | K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K792558 | Container SystemSummary page 1…shape and can be used for up to 2,200 washing and sterilization cycles. Aesculap's Reusable filters are to be used in conjunction with Aesculap's Sterilcontainer System (K792558). PERFORMANCE DATA No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these… | 1979 |
| * | K850289 | Monarch Sterilization Container SystemSummary page 1…sic operating principles to the following predicate devices: *Aesulap's Sterilcontainer System (K792558) *Johnson & Johnson's Sterion container (K850289) *Medline's Steriset container (K0l 0825) 4… | 1985 |
| * | K010825 | Medline Steriset Sterilization Container | 2001 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073168 | Aesculap Primeline Container LTD. | 2008 | 9 |
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.
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?
Aesculap's Reusable Sterilcontainer Filter (JK090) is a PTFE (Polytetrafluoroethylene) filter that allows for thorough penetration and evacuation of the sterilant (steam), while maintaining an effective barrier against microbial contamination for a maximum of 2,200 uses. This filter is for use with the Aesculap Sterilcontainer System in prevacuum steam sterilization cycle for 5 minutes at 273°F.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041623: Reusable Sterilcontainer Filter Model #JK090.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041623
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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