# K130304: Lma Family of Airways

- Pathway: 510(k) (Traditional)
- Applicant: The Laryngeal Mask Co., Ltd.
- Decided: May 30, 2014 after 477 days
- Product code: CAE (Airway, Oropharyngeal, Anesthesiology)
- Device class: 1
- Regulation: 21 CFR 868.5110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K903730 (1990). 18 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904834: Intavent Laryngeal Mask, Intavent Intl. S.A. (1991) Summary page 1.
- K991580: Ilm Endotracheal Tube, The Laryngeal Mask Co., Ltd. (2000) Summary page 1.
- K051993: Lma Fastrach Ett Single Use, The Laryngeal Mask Co., Ltd. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K001425: LMA Supreme. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6.

## Most influential descendants
- K142103: Cuff Pilot, Sure Seal (2015), 3 descendants of its own
- K160694: Disposable Endotracheal tube, sterile, AccuCuff (2017), 1 descendant of its own
- K190274: Endotracheal Tube (2019), 0 descendants of its own
- K182548: Accucuff Cuff Pressure Indicator (2019), 0 descendants of its own

## Indications for use
The LMA Unique™, LMA Classic™, LMA Classic Excel™, LMA Flexible™, LMA Flexible™ Single Use, LMA ProSeal™, LMA Fastrach™ Single Use, and LMA Supreme™ are devices inserted into a patient's pbarynx through the mouth to provide a patent airway. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field. The LMA Fastrach™ Eli' (reusable) and LMA FastrachTh Efl Single Use are indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Source page: https://510kreport.com/device/K130304
Methodology: https://510kreport.com/methodology