STERILIZATION OF DEVICES BY RADIATION— 510(k) K874659

Substantially Equivalent

Inhalation Plastics

FDA 510(k) clearance K874659 for STERILIZATION OF DEVICES BY RADIATION, Substantially Equivalent on 1988-02-02. Applicant: Inhalation Plastics.

Clearance details

Applicant: Inhalation Plastics
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 1987-10-20
Decision date: 1988-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.