510(k) · Cleared
ClearedSteriTite rigid reusable sterilization container with MediTray Products
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Case Medical · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 31, 2024 as substantially equivalent to K212711 (Case Medical, Inc., 2022) after a 121-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.
- Decided
- Jul 31, 2024
- Review
- 121 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K871202 (1987). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 3 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 2 generations backK173259 Case Medical SteriTite Reusable Rigid Sterilization Container System…Case Medical, Inc. · 2018
- 1 generation backK212711 SteriTite Container System with MediTray ProductsCase Medical, Inc. · 2022
- This deviceK240898 SteriTite rigid reusable sterilization container with MediTray…Case Medical · 2024
- Descendant · cites it directly · 0 of its ownK252854 SteriTite Container System with MediTray ProductsCase Medical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252854SteriTite Container System with MediTray ProductsCase Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −3 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −2 | K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with… | Case Medical, Inc. | 2018 | — |
| −1 | K212711 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2022 | — |
| 0 (this device) | K240898 | SteriTite rigid reusable sterilization container with MediTray Products | Case Medical | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K212711 | SteriTite Container System with MediTray ProductsSummary page 6…Product Code KCT Review Panel General Hospital Establishment Registration Number 2248608 Predicate Device K212711 -SteriTite Rigid Container Sterilization System with and MediTray products Description of Device The SteriTite® Univ… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252854 | SteriTite Container System with MediTray Products | 2026 | 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?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K252854 (Case Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K212711.
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. 2024, 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 device until it is used. The solid and perforated bottom container configurations are compatible for use with the following low temperature…
Read the full statement (130 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 device until it is used. The solid and perforated bottom container configurations are compatible for use with the following low temperature sterilizers and cycles identified below:
- STERIS V-Pro 60: Flexible and Lumen cycle (Solid and perforated bottom container)
- STERIS V-Pro s2: Flexible and Lumen cycle (Solid and perforated bottom container)
- STERIS V-Pro maX 2: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container)
- STERIS V-Pro maX: Lumen, Non-Lumen and Flexible cycle (Solid and perforated bottom container)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240898 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240898: SteriTite rigid reusable sterilization container with MediTray Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240898
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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