510(k) · Cleared
ClearedSteritite Container System & 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 Jul 1, 2011 as substantially equivalent to K080558 (Case Medical, Inc., 2008) and 1 other predicate after a 113-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Jul 1, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K040865 (2004). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK040865 Aesculap Sterrad 100S Compatable SterilcontainerAesculap · 2004
- 1 generation backK093493 Aesculap Sterilcontainer SAesculap, Inc. · 2010
- This deviceK110682 Steritite Container System & Meditray ProductsCase Medical, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK161415 SteriTite Containers System & MediTray ProductsCase Medical, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K161415SteriTite Containers System & MediTray ProductsCase Medical, Inc. · 2017 · cites it directly0descendants
View 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 | K093493 | Aesculap Sterilcontainer S | Aesculap, Inc. | 2010 | — |
| 0 (this device) | K110682 | Steritite Container System & Meditray Products | Case Medical, Inc. | 2011 | — |
| +1 | K161415 | SteriTite Containers System & MediTray Products | Case Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K080558 | Steritite Container System & Meditray ProductsSummary page 1…ntainer system is substantially equivalent to: * SteriTite* universal container system -anodized- previously cleared for STERRAD NX, 510(K) #K(080558. * Aesculap6 SterilContainer S non-anodized previously cleared for STERRAD 100NX, 510(k) K(093493.… | 2008 |
| * | K093493 | Aesculap Sterilcontainer SSummary page 1…eared for STERRAD NX, 510(K) #K(080558. * Aesculap6 SterilContainer S non-anodized previously cleared for STERRAD 100NX, 510(k) K(093493. 1 5.2… | 2010 |
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 |
|---|---|---|---|
| K161415 | SteriTite Containers System & MediTray Products | 2017 | 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 7 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K161415 (Case Medical, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K080558.
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. 2011, 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 universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices and instrumentation to be sterilized, transported and stored by health care providers. The container consists of a perforated base and lid with filter retention plates~ and disposable polypropylene filters. The SteriTite universal container system is compatible for use with STERRAD 100NX…
Read the full statement (201 words)
The SteriTite universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices and instrumentation to be sterilized, transported and stored by health care providers. The container consists of a perforated base and lid with filter retention plates~ and disposable polypropylene filters. The SteriTite universal container system is compatible for use with STERRAD 100NX Sterilization (Standard and Flex cycles). The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts including brackets, posts and partitions. The container may be used for sterilization of medical devices including full instrument sets and mixed loads.
SteriTite universal container system is recommended to be used for sterilization of surfaces and lumens:
- In STERRAD 100NX Standard cycle, process stainless steel lumens instruments of 0.7 mm diameter or larger and up to 500 mm in length.
- In STERRAD 100NX Flexible cycle, process flexible endloscopes, PE/PTFE Lumen instruments of :1.2 mm x 835 mm.
120 days of real time Shelf life testing with handling events has been conducted for SteriTite containers after STERRAD 100NX Sterilization.
Reuse testing was performed after 501 STERRAD 100NX Standard cycles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110682 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110682: Steritite Container System & Meditray Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110682
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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