| K-number | K251101 |
| Device name | AIRO Suction Unit (AIRO-01) |
| Applicant | Cro, LLC |
| Product code | BTA |
| Device class | Class II |
| Decision date | Apr 26, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4780 |
The AIRO Suction Unit (AIRO-01) is a portable, battery-powered medical suction device designed for emergency airway management by professional medical providers. It removes secretions such as blood or vomit during intermittent suction procedures and is indicated for use in adult patients.
The AIRO is more compact (7.58" × 3.25" × 2.5") and lighter (1.3 lbs) than the predicate SSCOR Quickdraw (10.5" × 4.35" × 4.5", 2.6 lbs). It achieves a continuous vacuum range of 20–550 mmHg with a low nominal airflow rate of 0.75 LPM, powered by four CR123 lithium-ion batteries, and uses a 500 mL disposable collection bag instead of a rigid canister.
The device was tested to ISO 10079-1:2015 and ISO 10079-4 standards for safety and performance. A distribution study followed ISTA (International Safe Transit Association) standards, and a usability study was performed with intended users.
Although the AIRO differs from the predicate in size, power source, airflow rate, and battery technology, these differences enhance portability and usability without raising new safety or effectiveness concerns. Testing to ISO 10079-1 and ISO 10079-4, distribution and usability studies all demonstrated that the device performs safely and effectively. The same indications for use, compatible tip dimensions, and similar vacuum pressure ranges support substantial equivalence despite the technological improvements.
View the full FDA submission: accessdata.fda.gov