# K190667: Sonopet iQ Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Medical
- Decided: Jun 13, 2019 after 90 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: 6 generations back to K844002 (1984). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152951: Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray, Paragon Medical, Inc. (2015) Summary page 4.

## Indications for use
The Sonopet iQ Sterilization Tray is intended to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The trays are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The Sonopet iQ Sterilization Tray is intended for use in any of the following standard sterilization cycles: Method: Pre-vacuum Steam Parameter: Enclosure Cycle 1: Double Wrap or Rigid Container Cycle 2: Double Wrap or Rigid Container Parameter: Temperature Cycle 1: 132°C (270°F) Cycle 2: 134°C (273°F) Parameter: Sterilization Time Cycle 1: 4 minutes Cycle 2: 3 minutes Parameter: Dry Time Cycle 1: 30 minutes Cycle 2: 30 minutes The maximum product load for the tray is as follows: Tray Description: Sonopet iQ Sterilization Tray Catalog Number: 5500-800-278 Maximum Tray Product Load: Handpiece (Qty 1), Cleaning Wire (Qty 1), Torque Wrench (Qty 1) Maximum Tray Weight: 6.85 lb

Source page: https://510kreport.com/device/K190667
Methodology: https://510kreport.com/methodology