# K243589: PAL Sterilization Case

- Pathway: 510(k) (Traditional)
- Applicant: Microaire Surgical Instruments, LLC
- Decided: Jun 20, 2025 after 212 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: 7 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)
- K180915: Sonicision Reusable Sterilization Tray, Covidien (2018) Summary page 5.

## Indications for use
The PAL Sterilization Case is a reusable sterilization case intended to provide storage for the PAL handpiece, the PAL cable, and 4 PAL cannulas during sterilization, storage, and transportation within the hospital environment. The PAL Sterilization Case is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with FDA-cleared sterilization wraps. The PAL Sterilization Case has only been evaluated for a non-stacked configuration. The validated steam sterilization parameters are listed below: Cycle Type: Pre-Vacuum; Exposure Temperature: 132 °C (270 °F); Exposure Time: 4 minutes; Minimum Dry Time: 20 minutes; Compatible Sterile Barriers: Wrap(s) Cycle Type: Gravity; Exposure Temperature: 121 °C (250 °F); Exposure Time: 30 minutes; Minimum Dry Time: 20 minutes; Compatible Sterile Barriers: Wrap(s)

Source page: https://510kreport.com/device/K243589
Methodology: https://510kreport.com/methodology