K252374

Substantially Equivalent

Nylon flexTAP(R)

Applicant: Airway Technologies D/B/A Airway Management
Product code: LRK
Advisory panel: Dental
Date received: 2025-07-30
Decision date: 2025-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Farmers Branch, TX, US

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.