FDA applicant
The Laryngeal Mask Co., Ltd.
FDA records 4 decisions for The Laryngeal Mask Co., Ltd. (San Diego, CA) from 2000 to 2014: 4 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and FFK (Lithotriptor, Electro-Hydraulic). Its devices cite 10 predicates, 3 of them its own earlier devices. 7 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided The Laryngeal Mask Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
7in 2018
Class I Class II/III not classified
Planning a device like The Laryngeal Mask Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report