# K110500: Stat-Mat Minor

- Pathway: 510(k) (Traditional)
- Applicant: Macpherson Medical, Inc.
- Decided: Jun 23, 2011 after 121 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: 4 generations back to K844002 (1984). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002) Summary page 1.
- K993535: Metapak Multi-Purpose Instrument Tray, Riley Medical, Inc. (2001) Summary page 1.

## Indications for use
The Stat-Mat® Minor multipurpose surgical instrument tray is used for loading an entire kit of surgical instruments for a specific case in order to conveniently organize, sterilize, transport and store the instruments between uses. The Stat-Mat®)Minor is designed using plastic and metal materials that can be reused with pre-vacuum or gravity displacement steam sterilization methods. The Stat-Mat® Minor should be used only with FDA-cleared and legally marketed sterilization wraps that have been cleared for the sterilization cycles listed below. The Stat-Mat® Minor has been validated with the Dextex 1I Sterilization Wrap [K800123]. The base containing organized surgical instrumentation can be placed directly on the back table or onto a Mayo Tray. Instruments with lumens were not tested in the Stat-Mat® Minor validation process and are therefore not recommended for use with the Stat-Mat® Minor. Sterilization cycle parameters: Cycle Type Temperature Sterilization Time Pre-Vac Pulses Dry Time Gravity 2500 F (121CC) 30 minutes none 30 minutes Pre-vacuum 2700 F (132 0C) 4 minutes 4 30 minutes

Source page: https://510kreport.com/device/K110500
Methodology: https://510kreport.com/methodology