# K040223: Polyvac Instrument Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Symmetry Medical USA, Inc.
- Decided: Oct 22, 2004 after 263 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). 8 ancestors in all.
46 later devices descend from it; 7 cite it directly.
0 of 55 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 3.
- K013003: Aptimax Instrument Tray, Instrument Mat and Instrument Holder, Advanced Sterilization Products (2002) Summary page 3.
- K993535: Metapak Multi-Purpose Instrument Tray, Riley Medical, Inc. (2001) Summary page 3.

## Most influential descendants
- K131455: Restore Modular Sterilization Tray System (2013), 30 descendants of its own
- K120947: THS Instrument Tray (2012), 30 descendants of its own
- 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

## Indications for use
PolyVac's delivery systems consist of perforated trays with lids, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing sterilant penetration and air removal, When used in conjunction with an approved sterilization wrap. Sterilization Method: Ethylene Oxide

Source page: https://510kreport.com/device/K040223
Methodology: https://510kreport.com/methodology