# K183139: Endoscope Sterilization Tray

- Pathway: 510(k) (Abbreviated)
- Applicant: Intuitive Surgical, Inc.
- Decided: Feb 1, 2019 after 80 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K013003 (2002). 7 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180964: Endoscope Sterilization Tray, Intuitive Surgical, Inc. (2018) Summary page 4.

## Most influential descendants
- K232610: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (2024), 11 descendants of its own
- K251739: da Vinci Surgical System (IS5000) (2026), 2 descendants of its own
- K241284: da Vinci Surgical System (IS5000) (2024), 2 descendants of its own
- K251202: da Vinci Surgical System (IS5000) (2025), 1 descendant of its own
- K243641: da Vinci Surgical System (IS5000) (2024), 1 descendant of its own

## Recalls of this device
- Dec 19, 2019 · Class II · Z-2328-2020: Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and r

## Indications for use
The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes for sterilization in any of the following sterilization machines/cycles: • STERRAD 100NX sterilization system using the Express and DUO cycles • STERRAD 100S sterilization system using the Standard cycle • Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles • Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles • Steris V-PRO 1 using the V-PRO/Lumen cycle The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 12.2 lbs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

Source page: https://510kreport.com/device/K183139
Methodology: https://510kreport.com/methodology