# K012105: Polyvac Surgical Instrument Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Symmetry Medical, Inc.
- Decided: Aug 2, 2002 after 393 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: 3 generations back to K844002 (1984). 5 ancestors in all.
149 later devices descend from it; 21 cite it directly.
1 of 155 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944025: Surgical Instrument Tray, Riley Medical, Inc. (1994) Summary page 3.
- K990761: Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette, Tuttnauer U.S.A Co, Ltd. (1999) Summary page 3.
- K980065: C/T Med-Systems Cassette System, C/T Med System, Ltd. (1998) Summary page 3.

## Most influential descendants
- K033222: Olympus Sterilization Trays (2004), 58 descendants of its own
- K040223: Polyvac Instrument Delivery System (2004), 46 descendants of its own
- K023658: Sterilization Cases and Trays (2003), 43 descendants of its own
- K052992: Conmed Linvatec Instrument Sterilization Tray (2006), 42 descendants of its own
- K142519: InterActive Complete Surgical Tray (2015), 30 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 steam penetration and air removal. When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used. PolyVac's delivery systems are to be sterilized in one of the following cycles: Prevacuum Steam : 132°C - 4 minutes minimum Gravity Steam: 132°C - 30 minutes minimum Gravity Steam: 121°C - 55 minutes minimum

Source page: https://510kreport.com/device/K012105
Methodology: https://510kreport.com/methodology