510(k) K251101
K251101 is an FDA 510(k) premarket notification submitted by Cro, LLC for the device "AIRO Suction Unit (AIRO-01)". The FDA issued a decision of Substantially Equivalent on April 26, 2025. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2025
- Date Received
- April 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type