# K253187: SteriBest® Sterilization Tray System

- Pathway: 510(k) (Traditional)
- Applicant: Mastel Surgical
- Decided: Jun 18, 2026 after 265 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K133015 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171520: SteriZign Signatur Device Protection System, Sterizign Precision Technologies, LLC (2018) Summary page 6.

## Indications for use
SteriBest® Sterilization Tray Systems are intended to organize, transport, store, and protect surgical and other medical devices during sterilization and between clinical uses. The trays are designed to allow sterilization of the enclosed medical devices during validated pre-vacuum steam sterilization cycles. The SteriBest® Sterilization Tray Systems are not intended, on their own, to maintain sterility. The trays have perforations to permit sterilant penetration and must be used with a legally marketed, sterile barrier to maintain sterility until point of use. Validated Sterilization Parameters: Method Pre-Vacuum Steam Temperature 270 °F (132 °C) Exposure Time 4 minutes Dry Time 30 minutes Maximum Load per Tray (Tray+ Instruments): Tray Part Number Maximum Load (g) CP614 1794 CP634 1794 CP778 1794 CP471D1 366 CP471S 1794 CP1038D1 1049 CP1038D2 1794 CP1038S 1794 Validated Lumen Claims (Per Tray): Validated lumens consisted of stainless steel. Base and Lids (Tray) count of lumens ID of lumen (mm) Part Number CP471D 4 1.0 CP1038D1 5 1.0 CP614 10 1.0 CP634 10 1.0 CP778 10 1.0 CP471S 10 1.0 CP1038D2 10 1.0 CP1038S 10 1.0 length of lumen (mm) 152 152 152 152 152 152 152 152

Source page: https://510kreport.com/device/K253187
Methodology: https://510kreport.com/methodology