Class Class II
PnueAira (PNCU-01) (K251086)
Description
PnueAira (PNCU-01) by Biotab, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251086
Clearance Date2025-08-18
Clearance TypeTraditional
Product CodeJOW
Regulation Number870.5800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251086
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. PnueAira (PNCU-01) (K251086) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223195 | AIROS 6P Sequential Compression Device | Airos Medical, Inc. | 2022 |
| K182003 | Lympha Press Optimal Plus | Mego Afek AC , Ltd. | 2019 |
Trace the full predicate network for K251086
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.