# K152014: MTS300 Multiple Tray Sterilization System

- Pathway: 510(k) (Traditional)
- Applicant: Pmbs, LLC
- Decided: Oct 20, 2015 after 91 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: 1 generation back to K110898 (2012). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110898: S.C.O.R.E.S. Unit, Ammed Surgical Equipment, LLC (2012) Summary page 4.

## Most influential descendants
- K190541: MTS225 and MTS300 Multiple Tray Sterilization Systems (2019), 1 descendant of its own
- K222328: SteriCUBE® Multiple Tray Sterilization Systems (2022), 0 descendants of its own

## Indications for use
The MTS300 System is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit must be used with the MTS300 Transfer Cart, MTS300 filters and integrity locks. The MTS300 System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray. The MTS300 System was tested and validated with rigid instruments containing lumens with an inner diameter of 3.8mm and an overall length of 370mm. Do not use with instruments containing lumens with an inner diameter smaller than 3.8mm and an overall length longer than 370mm. Use only uncovered, perforated or wire mesh general delivery trays within the MTS300 System.

Source page: https://510kreport.com/device/K152014
Methodology: https://510kreport.com/methodology