CONCEPT ENDOTRACHEAL TUBE— 510(k) K801213

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K801213 for CONCEPT ENDOTRACHEAL TUBE, Substantially Equivalent on 1980-05-28. Applicant: Concept, Inc..

Clearance details

Applicant: Concept, Inc.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1980-05-20
Decision date: 1980-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.