Class Class II
PAL 7020 Console (K244026)
Description
PAL 7020 Console by Microaire Surgical Instruments, LLC, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK244026
Clearance Date2025-04-25
Clearance TypeTraditional
Product CodeQPB
Regulation Number878.5040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K244026
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 7020 Console (K244026) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | Mentor Worldwide, LLC | 2016 |
Trace the full predicate network for K244026
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.