510(k) · Cleared
ClearedSteriTite Container System with MediTray Products
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Case Medical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jun 3, 2026 as substantially equivalent to K240898 (Case Medical, 2024) after a 268-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Jun 3, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K871202 (1987). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 4 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 3 generations backK173259 Case Medical SteriTite Reusable Rigid Sterilization Container System…Case Medical, Inc. · 2018
- 2 generations backK212711 SteriTite Container System with MediTray ProductsCase Medical, Inc. · 2022
- 1 generation backK240898 SteriTite rigid reusable sterilization container with MediTray…Case Medical · 2024
- This deviceK252854 SteriTite Container System with MediTray ProductsCase Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −4 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −3 | K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with… | Case Medical, Inc. | 2018 | — |
| −2 | K212711 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2022 | — |
| −1 | K240898 | SteriTite rigid reusable sterilization container with MediTray Products | Case Medical | 2024 | — |
| 0 (this device) | K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K240898 | SteriTite rigid reusable sterilization container with MediTray ProductsSummary page 9…Class II Product Code: KCT Review Panel: General Hospital Establishment Registration Number: 2248608 Predicate Device: K240898 -SteriTite Rigid Container Sterilization System with and MediTray products Description of Device: The SteriTite® Universa… | 2024 |
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 39 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
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. 2026, 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 SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed devices until it is used. The perforated bottom container configuration is compatible for use with the following steam sterilization cycles…
Read the full statement (282 words)
The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed devices until it is used.
The perforated bottom container configuration is compatible for use with the following steam sterilization cycles:
Steam Cycle with Steam Flush Pressure Pulses (SFPP):
-At 132°C for 4 minutes with a 30-minute dry time
-At 135°C for 3 minutes with a 30-minute dry time
Note: The validation studies were performed using a 4 SFPP cycle with a validation load consisting of unwrapped metal items with a total weight of 25 lbs. (including the SteriTite container).
In addition, the SteriTite container, also available with a solid bottom, is compatible with low-temperature sterilizers, and is compatible with the following sterilizers and cycles identified below:
- SteriTite solid bottom Container: STERRAD 100NX - Express Cycle (surface sterilization of medical devices only; no lumens).
Note: The validation studies were performed using a validation load consisting of a da Vinci X/Xi 8mm Endoscope with a total weight of 22.4 lbs. (including the SteriTite container).
- SteriTite solid bottom Container: STERRAD 100NX - DUO Cycle (surface sterilization of medical devices only; no lumens).
Note: The validation studies were performed using a validation load consisting of non-lumened devices with a total weight of 13.2 lbs. (including the SteriTite container).
Refer to the specific Sterilizer user manual for information regarding the processing of appropriate devices and device types. See labeling for tables of compatible devices and maximum load weight recommendations including the weight of the sterilization container.
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/K252854 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252854: SteriTite Container System with MediTray Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252854
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026