510(k) · Cleared
ClearedSterilContainer S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Oct 9, 2015 as substantially equivalent to K093649 (Aesculap, 2010) after a 151-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Oct 9, 2015
- Review
- 151 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040865 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK040865 Aesculap Sterrad 100S Compatable SterilcontainerAesculap · 2004
- 1 generation backK093649 Aesculap Sterilcontainer SAesculap · 2010
- This deviceK151242 SterilContainer SAesculap, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK162815 SterilContainer S SystemAesculap, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK193582 SterilContainer S2 SystemAesculap, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040865 | Aesculap Sterrad 100S Compatable Sterilcontainer | Aesculap | 2004 | — |
| −1 | K093649 | Aesculap Sterilcontainer S | Aesculap | 2010 | — |
| 0 (this device) | K151242 | SterilContainer S | Aesculap, Inc. | 2015 | — |
| +1 | K162815 | SterilContainer S System | Aesculap, Inc. | 2017 | — |
| +2 | K193582 | SterilContainer S2 System | Aesculap, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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 KCT? 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 KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K093649 | Aesculap Sterilcontainer SSummary page 8…platforms COMPARISON TO PREDICATE The SterilContainer S that can be used in the Amsco® V-PRO™ maX Flexible Cycle is the same container system as was cleared in K093649. The materials and design have not changed. System SterilContainer S Aesculap SterilCo… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162815 | SterilContainer S System | 2017 | 1 |
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 11 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162815 (Aesculap, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K093649.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, 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 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
The SterilContainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene 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 system is compatible for…
Read the full statement (376 words)
The SterilContainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene 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 system is compatible for use with the V-PRO maX Low Temperature Sterilization System Flexible Cycle.
Table 1: Validated V-PRO maX Sterilizer Flexible Cycle Load Configurations
Load Configuration 1: Two SterilContainer S containers each with a basket, mat, accessories and a flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and no additional load. The flexible endoscopes may contain either: a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter; or two lumens: one lumen with an inside diameter of 1 mm or larger and length of 990 mm or shorter; the second lumen with an inside diameter of 1 mm or larger and length of 850 mm or shorter.
Load Configuration 2: Two SterilContainer S containers, each with a basket, mat and accessories. The first SterilContainer S container holds a flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and no additional load. The flexible endoscopes may contain either: a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter; or two lumens: one lumen with an inside diameter of 1 mm or larger and length of 990 mm or shorter; the second lumen with an inside diameter of 1 mm or larger and length of 850 mm or shorter. The second SterilContainer S container holds reusable metal and non-metal non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. The total load weight validated was 24 lbs. The validation studies were conducted with a flexible endoscope in a SterilContainer S container with basket, silicone mat, accessories and light cord (if not integral to endoscope). Also included in the load was an additional SterilContainer S container with instruments for a total load weight of 24.0 lbs.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151242: SterilContainer S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151242
Report an extraction error
Are you the manufacturer?
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