Class Class II
PAL Sterilization Case (K243589)
Description
PAL Sterilization Case by Microaire Surgical Instruments, LLC, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243589
Clearance Date2025-06-20
Clearance TypeTraditional
Product CodeKCT
Regulation Number880.6850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243589
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. PAL Sterilization Case (K243589) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180915 | Sonicision Reusable Sterilization Tray | Covidien | 2018 |
Trace the full predicate network for K243589
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.