# K052567: One Tray Sealed Sterilization Container

- Pathway: 510(k) (Traditional)
- Applicant: Sterile Containment Technology, LLC
- Decided: Mar 13, 2006 after 175 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871202 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960738: Steritite Sealed Container (SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H), Engineered Custom Mfg., Inc. (1997) Summary page 1.
- K022978: Steritite Container with Flashtite Valve Plate (S) & Meditray Products, Case Medical, Inc. (2003) Summary page 1.
- K833343: Sterilization Container, Medin Corp. (1983) Summary page 1.
- K871202: Flashpak Container System, Performance Instruments Corp. (1987) Summary page 1.

## Recalls of this device
- Feb 3, 2014 · Class II · Z-0153-2016: 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.

## Indications for use
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)

Source page: https://510kreport.com/device/K052567
Methodology: https://510kreport.com/methodology