OHIO DISPOSABLE TRACHEAL TUBE— 510(k) K800634

Substantially Equivalent

Ohio Medical Products

FDA 510(k) clearance K800634 for OHIO DISPOSABLE TRACHEAL TUBE, Substantially Equivalent on 1980-04-02. Applicant: Ohio Medical Products.

Clearance details

Applicant: Ohio Medical Products
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1980-03-21
Decision date: 1980-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.