510(k) · Cleared
ClearedONE TRAY® Sealed Sterilization Container System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Sterilization Technologies · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on May 1, 2025 as substantially equivalent to K214041 (Aesculap, Inc., 2022) after a 115-day review. Its family tree reaches back 7 generations to 1987.
- Decided
- May 1, 2025
- Review
- 115 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K871202 (1987). 15 ancestors in all, the oldest K792558 (1979). No later device cites it as a predicate yet.
- Root · 7 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 6 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 5 generations backK053389 Aesculap Sterilcontainer SystemAesculap, Inc. · 2006
- 4 generations backK073168 Aesculap Primeline Container LTD.Aesculap, Inc. · 2008
- 3 generations backK112671 Sterilcontainer SystemAesculap, Ltd. · 2012
- 2 generations backK192056 JJ Series Container SystemAesculap, Inc. · 2020
- 1 generation backK214041 Aesculap AICON ContainerAesculap, Inc. · 2022
- This deviceK250029 ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −6 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −5 | K053389 | Aesculap Sterilcontainer System | Aesculap, Inc. | 2006 | — |
| −4 | K073168 | Aesculap Primeline Container LTD. | Aesculap, Inc. | 2008 | — |
| −3 | K112671 | Sterilcontainer System | Aesculap, Ltd. | 2012 | — |
| −2 | K192056 | JJ Series Container System | Aesculap, Inc. | 2020 | — |
| −1 | K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022 | — |
| 0 (this device) | K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 3 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K214041 | Aesculap AICON ContainerSummary page 6…lassification: Class 2 Medical Specialty (Panel): Infection Control Devices Branch 3. PREDICATE DEVICES • Predicate Device - Aesculap AICON Container – K214041 • Reference Device - IST ONE TRAY® sealed sterilization container – K052567… | 2022 |
| † | K052567 | One Tray Sealed Sterilization Container | 2006 |
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 38 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 3 other devices also cite its predicate K214041.
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. 2025, 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 ONE TRAY Container is a reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of 1he enclosed devices during storage, transport and until used. This container is compatible for use in the following sterilization modalities in the configuration listed below: Prevac…
Read the full statement (231 words)
The ONE TRAY Container is a reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of 1he enclosed devices during storage, transport and until used. This container is compatible for use in the following sterilization modalities in the configuration listed below:
Prevac Steam
270°F, 4 min exposure
15 minute dry time
ONE TRAY® is validated to process a twenty five pound (25 lb) gross weight load (single container plus contents). This includes sterilization of lumens (Stainless Steel and Titanium) 1 mm in diameter or larger with lengths of up to 500 mm.
DO NOT STACK ONE TRAY CONTAINERS DURING STERILIZATION.
Examples of validated materials that can be processed within the ONE TRAY - Metals: S1ainless Steel, Titanium, Aluminum, Thermoplastics: PEEK, Polypropylene, Radel, Thermosetting Polymers: Silicone, Phenolic.
The ONE TRAY® sealed sterilization container consists of a line of rigid reusable containers listed in the table below. Healthcare Facilities should follow steam sterilization cycle and storage guidelines as stated in AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
Catalog# Length (in) Width (in) Height (in)
M2104DT 20.142 11.616 4.573
M2106DT 20.142 11.616 6.573
M2108DT 20.142 11.616 8.573
M2404DT 23.142 11.616 4.573
M2406DT 23.142 11.616 6.573
M2408DT 23.142 11.616 8.573
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250029: ONE TRAY® Sealed Sterilization Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250029
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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