# K062231: MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001

- Pathway: 510(k) (Special)
- Applicant: Minrad, Inc.
- Decided: Aug 31, 2006 after 29 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: 1 generation back to K970619 (1997). 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)
- K970619: Greatbatch Scientific Mri Compatible Fiber Optic Laryngoscope Handle, Wilson Greatbatch Technologies, Inc. (1997) Summary page 1.
- (no number) Laryngoscope, Welch Allyn: named in the summary without a submission number
- (no number) Laryngoscope, Sun Med: named in the summary without a submission number

## Indications for use
The MiR MR Fiber Optic Intubating Laryngoscope Handle, Standard ("MINILAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Standard") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Source page: https://510kreport.com/device/K062231
Methodology: https://510kreport.com/methodology