# K182052: Omni Instrument Tray

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Feb 26, 2019 after 210 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121280: Myosure Intrument Tray, Hologic, Inc. (2013) Summary page 4.

## Indications for use
The Omni Instrument Tray is intended to enclose, protect, and organize The Omni Hysteroscope, Sheaths, and Removable Outflow Channels during sterilization and storage. The Omni Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycles. The Omni Instrument Tray has been validated for the following sterilization cycles: Pre-vacuum Steam 132°C (270°F) 4 minutes exposure 35 minutes dry time Contents: - 1 Omni Hysteroscope -1 Removable Outflow Channel -1 XL Removable Outflow Channel -1 Omni 3.7mm Diagnostic Sheath -1 Omni 5.5mm Operative Sheath - 1 Omni 6mm Operative Sheath - 3 Seal Caps - 2 Light Guide Adapters STERRAD® STERRAD NX™ Standard STERRAD 100NX™ Standard STERRAD 100S Short Contents: - 1 Omni Hysteroscope -1 Removable Outflow Channel -1 XL Removable Outflow Channel -1 Omni 3.7mm Diagnostic Sheath -1 Omni 5.5mm Operative Sheath - 1 Omni 6mm Operative Sheath - 3 Seal Caps - 2 Light Guide Adapters

Source page: https://510kreport.com/device/K182052
Methodology: https://510kreport.com/methodology