# K062523: Tru-MR Laryngoscope Set

- Pathway: 510(k) (Traditional)
- Applicant: Truphatek International, Ltd.
- Decided: Nov 17, 2006 after 81 days
- Product code: CCW (Laryngoscope, Rigid)
- Device class: 1
- Regulation: 21 CFR 868.5540
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041852 (2004). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041852: MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002, Minrad, Inc. (2004) Summary page 1.

## Most influential descendants
- K140951: Yeescope Laryngoscopes (2014), 0 descendants of its own
- K121378: Airtraq SP Airtraq Avant (2012), 0 descendants of its own

## Recalls of this device
- Mar 1, 2007 · Not classified · Z-0758-2007: The MRI Battery is out of specification for its magnetic content.

## Indications for use
The Tru-MR TM laryngoscope set is used 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/K062523
Methodology: https://510kreport.com/methodology