AIRO Suction Unit (AIRO-01)— 510(k) K251101
Substantially EquivalentCro, LLC
FDA 510(k) clearance K251101 for AIRO Suction Unit (AIRO-01), Substantially Equivalent on 2025-04-26. Applicant: Cro, LLC. Device class: 2.
Clearance details
- Applicant
- Cro, LLC
- Product code
- Code BTA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Missoula, MT, US
Recent devices under product code BTA
view all- K253629 — Momcozy Nasal Aspirator (BN007)
- K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 +1 more
- K260892 — Suction Pump (SU-90)
- K260473 — Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
- K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
Adverse events under product code BTA
product code BTA- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.