# K190541: MTS225 and MTS300 Multiple Tray Sterilization Systems

- Pathway: 510(k) (Traditional)
- Applicant: Pmbs, LLC
- Decided: Nov 5, 2019 after 246 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 K110898 (2012). 2 ancestors in all.
1 later device descends 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)
- K152014: MTS300 Multiple Tray Sterilization System, Pmbs, LLC (2015) Summary page 4.

## Most influential descendants
- K222328: SteriCUBE® Multiple Tray Sterilization Systems (2022), 0 descendants of its own

## Indications for use
The MTS System (Multiple Tray Sterilization 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. The unit must be used with the MTS System Transfer Cart, MTS System Filters and MTS System Integrity Locks. The MTS 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 MTS System was tested and validated with rigid instruments containing lumens with an inner diameter of .7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than .7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm. Use only uncovered, perforated or wire mesh general delivery trays within the MTS System.

Source page: https://510kreport.com/device/K190541
Methodology: https://510kreport.com/methodology