Cleared Traditional

AIRO Suction Unit (AIRO-01)

K251101 · Cro, LLC · General & Plastic Surgery
Apr 2025
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K251101 is an FDA 510(k) clearance for the AIRO Suction Unit (AIRO-01), a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Cro, LLC (Missoula, US). The FDA issued a Cleared decision on April 26, 2025, 15 days after receiving the submission on April 11, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K251101 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2025
Decision Date April 26, 2025
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code BTA — Pump, Portable, Aspiration (manual Or Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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