510(k) · Cleared
Recalled · Class II · 2014One Tray Sealed Sterilization Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterile Containment Technology, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 13, 2006 as substantially equivalent to K960738 (Engineered Custom Mfg., Inc., 1997) and 3 other predicates after a 175-day review. Its family tree reaches back 2 generations to 1987. It has been recalled once.
- Decided
- Mar 13, 2006
- Review
- 175 days
- Class
- Class II
- Product code
- KCT
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K871202 (1987). 6 ancestors in all, the oldest K833343 (1983). No later device cites it as a predicate yet.
- Root · 2 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 1 generation backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- This deviceK052567 One Tray Sealed Sterilization ContainerSterile Containment Technology, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −1 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| 0 (this device) | K052567 | One Tray Sealed Sterilization Container | Sterile Containment Technology, LLC | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K960738 | Steritite Sealed Container (SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)Summary page 1…gulation No. 880.6850 Product Code: 80FRG Predicate Device Case Medical SteriTite® K960738 and K022978 Additional Predicate Devices Medin K833343 and FlashPak K871202 Device Description ONE TRAY® is a sealed rigid cont… | 1997 |
| * | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsSummary page 1…880.6850 Product Code: 80FRG Predicate Device Case Medical SteriTite® K960738 and K022978 Additional Predicate Devices Medin K833343 and FlashPak K871202 Device Description ONE TRAY® is a sealed rigid container with a… | 2003 |
| * | K833343 | Sterilization ContainerSummary page 1…880.6850 Product Code: 80FRG Predicate Device Case Medical SteriTite® K960738 and K022978 Additional Predicate Devices Medin K833343 and FlashPak K871202 Device Description ONE TRAY® is a sealed rigid container with a rectangular patterned group of perforations… | 1983 |
| * | K871202 | Flashpak Container SystemSummary page 1…Code: 80FRG Predicate Device Case Medical SteriTite® K960738 and K022978 Additional Predicate Devices Medin K833343 and FlashPak K871202 Device Description ONE TRAY® is a sealed rigid container with a rectangular patterned group of perforations forming vented areas… | 1987 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2014 | Class II | Z-0153-2016 | Process control | The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K960738.
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.
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?
ONE TRAY® Sealed Sterilization Containers are intended to be used to hold temperature tolerant medical devices, surgical supplies, single instruments, multiple instruments or an instrument set for immediate use following flash sterilization. This includes sterilization of lumens 3 mm in diameter or larger with lengths of up to 400 mm. ONE TRAY® Sealed Sterilization Containers are available in the following sizes: The ONE TRAY® components listed in the…
Read the full statement (241 words)
ONE TRAY® Sealed Sterilization Containers are intended to be used to hold temperature tolerant medical devices, surgical supplies, single instruments, multiple instruments or an instrument set for immediate use following flash sterilization. This includes sterilization of lumens 3 mm in diameter or larger with lengths of up to 400 mm.
ONE TRAY® Sealed Sterilization Containers are available in the following sizes:
The ONE TRAY® components listed in the preceding table have been validated in all of the various size configurations listed in the following table to process a twenty five pound (25 lb) gross weight load (single container plus contents) in a steam pre-vacuum cycle at 132°C for 4 minutes exposure time; or in a steam gravity cycle at 132°C for 34 minutes exposure time.
After sterilization, ONE TRAY provides for the safe transport and assured delivery for immediate use of the enclosed devices in a sealed container with tamper evident security and load record documentation according to AAMI and AORN guidelines.
The performance and intended use of ONE TRAY Sealed Sterilization Containers should comply at all times with the methods of use and flash sterilization guidelines as recommended by the manufacturer of the devices being sterilized, AAMI (Association for the Advance of Medical Instrumentation), AORN (Association of periaperative Nurses), ASHCSP (American Society of Healthcare Central Service Professionals), NIHSPO (National Institute for the Certification of Healthcare Sterile Processing and Distribution Personnel) and IAHCSMM (International Association of Healthcare Central Service Materiel Management)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052567: One Tray Sealed Sterilization Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052567
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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