510(k) · Cleared
ClearedSteriTite Container System with MediTray Parts
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 Oct 7, 2022 as substantially equivalent to K212711 (Case Medical, Inc., 2022) after a 137-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Oct 7, 2022
- Review
- 137 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. No later device cites it as a predicate yet.
- 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 deviceK221492 SteriTite Container System with MediTray PartsCase Medical, Inc. · 2022
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) | K221492 | SteriTite Container System with MediTray Parts | Case Medical, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K212711 | SteriTite Container System with MediTray ProductsSummary page 11…erilization Wrap Product Code KCT, Review Panel General Hospital Establishment Registration Number 2248608 Predicate Device K212711 -SteriTite Rigid Container Sterilization System with and MediTray Parts Description of Device Th… | 2022 |
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 35 years and passes through 2 companies; a new generation was cleared every 15.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 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. 2022, 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. This container system is compatible for use with the following low temperature sterilizers and cycles identified…
Read the full statement (315 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. This container system is compatible for use with the following low temperature sterilizers and cycles identified below:
- STERIS V-Pro 60 (Flexible and Lumen cycle)
- STERIS V-Pro s2 (Flexible and Lumen cycle)
- STERIS V-Pro maX 2 (Lumen, Non-Lumen and Flexible cycle)
- STERIS V-Pro maX (Lumen, Non-Lumen and Flexible cycle)
- STERRAD 100NX ALLCLEAR (Standard, Flexible, DUO and Express cycle)
- Sterizone VP4 (Cycle 1)
Refer to the specific Sterilizer user manual and vendor provided information regarding the processing of appropriate devices and device type. See the following pages for tables of compatible devices and description of the validated loads.
The following table (Table 1) identifies the validated lumen claims of the SteriTite container with MediTray parts in low temperature and pre-vacuum steam sterilizers:
Table 1. SteriTite Container System with MediTray Parts Lumen Claims:
Sterilizer Cycle Lumen Sterilization Claims (I.D. x Length)
STERIS V-Pro 60 Flexible >1mm x <990mm (Single or Dual Lumen)
STERIS V-Pro 60 Lumen >0.77mm x <527mm (Dual Channel)
STERIS V-Pro s2 Flexible >Imm x <990mm (Single or Dual Lumen)
STERIS V-Pro s2 Lumen >0.77mm x <527mm (Dual Channel)
STERIS V-Pro maX 2 Flexible >Imm x <1050mm (Single Lumen)
STERIS V-Pro maX 2 Lumen >0.77mm x <527mm (Dual Channel)
STERIS V-Pro maX Flexible >Imm x <1050mm (Single Lumen)
STERIS V-Pro maX Lumen >0.77mm x <527mm (Dual Channel)
STERRAD 100NX DUO >1mm x <875mm (Single Lumen)
Sterizone VP4 Cycle 1 >1.2mm x <1955mm (Flexible Lumens)
Sterizone VP4 Cycle 1 >1.45mm x <3500mm (Flexible Lumens)
Steam Pre-Vac >2mm x <400mm (Stainless Steel Lumen)
>1.2mm x <400mm (Flexible Lumen)
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/K221492 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221492: SteriTite Container System with MediTray Parts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221492
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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