TRACH TAPE— 510(k) K820099

Substantially Equivalent

Stan-Pak Ent.

FDA 510(k) clearance K820099 for TRACH TAPE, Substantially Equivalent on 1982-02-23. Applicant: Stan-Pak Ent..

Clearance details

Applicant: Stan-Pak Ent.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1982-01-13
Decision date: 1982-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.