# K103226: Sterilization Mats

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Feb 18, 2011 after 109 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 K013003 (2002). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013003: Aptimax Instrument Tray, Instrument Mat and Instrument Holder, Advanced Sterilization Products (2002) Summary page 2.

## Most influential descendants
- K140494: V-Pro Sterilization Tray/ Sterilization Mat (2014), 7 descendants of its own
- K160912: Sterilization Tray (2016), 6 descendants of its own
- K172755: PRO-LITE Sterilization Trays (2018), 5 descendants of its own
- K183402: PRO-LITE Sterilization Tray (2019), 3 descendants of its own
- K222440: Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays (2022), 2 descendants of its own

## Indications for use
The sterilization mats are intended to be used in conjunction with the V-PROTM Sterilization Trays (K(070769) to cushion and stabilize instruments during sterilization in the Amsco® V-PRO Low Temperature Sterilization Systems. The sterilization mats have been validated for use in the three pre-programmed V-PRO sterilization cycles [Lumen Cycle (the only cycle of the V-PRO I Sterilizer), Non Lumen Cycle, and Flexible Cycle]. The critical parameters for each of these cycles are listed below. The Lumen Cycle, cleared under K062297, can sterilize: • Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors • Medical devices with a single stainless steel lumen with: • an inside diameter of 1 mm or larger and a length of 125 mm or shorter • an inside diameter of 2 mm or larger and a length of 250 mm or shorter • an inside diameter of 3 mm or larger and a length of 400 mm or shorter The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays (containing two mats and 20 instrument organizers) and two pouches for a total weight of 19.65 lbs. The Non Lumen Cycle, cleared under K083097, can sterilize: Non-lumened instruments including non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. The validation studies were conducted using a validation load consisting of two instrument trays containing two mats, and 20 instrument organizers and two pouches for a total weight of 19.65 lbs. The Flexible Cycle, subject of K102330, can sterilize: Single or dual lumen surgical flexible endoscopes and bronchoscopes in either of two load configurations: 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either: • a single Teflon lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter • or two Teflon lumens with: • one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter • and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat, 20 instrument organizers and light cord (if not integral to endoscope). 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. The flexible endoscope can contain either: • a single Teflon lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter • or two Teflon lumens with: • one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter • and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter The validation studies were conducted with a flexible endoscope in a tray with silicone mat, 20 instrument organizers and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray (containing a mat and 20 instrument organizers) and one pouch for a total load weight of 24.0 lbs.

Source page: https://510kreport.com/device/K103226
Methodology: https://510kreport.com/methodology