# K131455: Restore Modular Sterilization Tray System

- Pathway: 510(k) (Traditional)
- Applicant: Restore Medical Solutions, Inc.
- Decided: Aug 30, 2013 after 102 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: 5 generations back to K844002 (1984). 9 ancestors in all.
30 later devices descend from it; 1 cites it directly.
0 of 40 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.
- K040223: Polyvac Instrument Delivery System, Symmetry Medical USA, Inc. (2004) Summary page 1.

## Most influential descendants
- K152241: Medtronic Transportation/Sterilization Cassettes (2016), 29 descendants of its own
- K163600: Kit Boxes and Kit Plates (2018), 18 descendants of its own
- K180791: Straumann BLX Surgical Cassette (2018), 11 descendants of its own
- K212281: Surgical Trays (2022), 5 descendants of its own
- K181075: PureSet Tray (2018), 5 descendants of its own

## Indications for use
The Restore™ Modular Sterilization Tray System is intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other Instrumentation between surgical and other medical uses when used In conjunction with a FDA cleared sterilization wrap. The Modular Sterilization Tray System may be used with common surgical Instruments such as hammers, rasps, drivers, chisels, ringed-handled instruments, rongeurs, pickups, including but not limited to short-lumened devices etc. The validated total weight for tray and contents was 20 pounds. Reusable Medical Device Challenge Conditions Minimum Inner Diameter: 1.8 mm; Maximum Length: 4 inches; Number of lumens: 2 High Vacuum (pre-vacuum, three pulse, standard): Temp: 270°F Exposure Time: 4 Minutes Cycle Dry Time (wrapped): 20 Minutes (minimum) Cool Time: Varies according to toad contents NOTE: Cool drafts from air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling syndrome.

Source page: https://510kreport.com/device/K131455
Methodology: https://510kreport.com/methodology