Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Laryngeal Mask Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130304 | LMA FAMILY OF AIRWAYS | The Laryngeal Mask Co., Ltd. | 2014-05-30 | 477 | 0 |
| K062475 | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM | The Laryngeal Mask Co., Ltd. | 2007-05-09 | 258 | 0 |
| K051993 | LMA FASTRACH ETT SINGLE USE | The Laryngeal Mask Co., Ltd. | 2005-12-13 | 141 | 0 |
| K991580 | ILM ENDOTRACHEAL TUBE | The Laryngeal Mask Co., Ltd. | 2000-02-04 | 273 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda