Class Class II
AIRO Suction Unit (AIRO-01) (K251101)
Description
AIRO Suction Unit (AIRO-01) by Cro, LLC, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251101
Clearance Date2025-04-26
Clearance TypeTraditional
Product CodeBTA
Regulation Number878.4780
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251101
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. AIRO Suction Unit (AIRO-01) (K251101) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K153459 | TACVAC | Athena Gtx | 2016 |
| K041154 | S-SCORT...JR QUICKDRAW, MODEL 2400 | Sscor | 2004 |
Trace the full predicate network for K251101
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.