# K251101: AIRO Suction Unit (AIRO-01)

- Pathway: 510(k) (Traditional)
- Applicant: Cro, LLC
- Decided: Apr 26, 2025 after 15 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K840110 (1984). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041154: S-Scort...JR Quickdraw, Model 2400, Sscor (2004) Summary page 5.
- K153459: Tacvac, Athena Gtx (2016) Summary page 5.

## Indications for use
The AIRO Suction Unit, Model AIRO-01, is a portable, battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.

Source page: https://510kreport.com/device/K251101
Methodology: https://510kreport.com/methodology