# K253437: Spiro-VISTA

- Pathway: 510(k) (Traditional)
- Applicant: Spiro Robotics
- Decided: Jun 12, 2026 after 254 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K110962 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110962: Ambu Ascope 2, Ambu A/S (2011) Summary page 5.

## Indications for use
The Spiro-VISTA system is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly during non-difficult and difficult tracheal intubation procedures. The system is for use in a hospital environment in adults that have been clinically evaluated for ETT size 5.0 to 7.0 mm ID.

Source page: https://510kreport.com/device/K253437
Methodology: https://510kreport.com/methodology