# K072211: Intuitive Surgical Instrument and Accessories Sterilization Trays

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Feb 28, 2008 after 203 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.
7 later devices descend from it; 1 cites it directly.
0 of 17 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.
- K032119: Paragon Medical Surgical Instrument Delivery System Various, Paragon Medical, Inc. (2003) Summary page 1.
- K033222: Olympus Sterilization Trays, Olympus Winter & Ibe GmbH (2004) Summary page 2.

## Most influential descendants
- K180127: TCAT (R) THA Instrument Tray Set (2019), 6 descendants of its own
- K200632: TCAT TKA Instrument Tray Set (2020), 5 descendants of its own
- K202268: CrossRoads Tray System (2020), 3 descendants of its own
- K241927: Synthes Graphic Case & Tray System (2025), 1 descendant of its own
- K253791: PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (2026), 0 descendants of its own

## Indications for use
Intuitive Surgical Instrument and Accessory Sterilization Trays are intended for the protection, organization and delivery to the surgical field of Intuitive Surgical EndoWrist instruments and Intuitive Surgical Re-usable Accessories ONLY, as listed in Table I below. The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components. Autoclave Sterilization Parameter: Cycle: Pre-vacuum Temperature: 270-272 0 F (132-1 34 0 C) Minimum Exposure Time: 4 mins Minimum Dry Time: 30 mins Table 2 provides the description of the 4 configurations of the Intuitive Surgical Instrument and Accessory Sterilization Trays

Source page: https://510kreport.com/device/K072211
Methodology: https://510kreport.com/methodology