# K121378: Airtraq SP Airtraq Avant

- Pathway: 510(k) (Traditional)
- Applicant: Prodol Meditec, Ltd.
- Decided: Jun 21, 2012 after 44 days
- Product code: CCW (Laryngoscope, Rigid)
- Device class: 1
- Regulation: 21 CFR 868.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K041852 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062523: Tru-MR Laryngoscope Set, Truphatek International, Ltd. (2006) Summary page 1.

## Indications for use
Airtraq® SP - MR and Airtraq® Avant are intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Source page: https://510kreport.com/device/K121378
Methodology: https://510kreport.com/methodology