ESPREE' BREATHING CIRCUIT (W/ACCESS— 510(k) K821311

Substantially Equivalent

Esp Plastics, Inc.

FDA 510(k) clearance K821311 for ESPREE' BREATHING CIRCUIT (W/ACCESS, Substantially Equivalent on 1982-05-21. Applicant: Esp Plastics, Inc..

Clearance details

Applicant: Esp Plastics, Inc.
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1982-05-04
Decision date: 1982-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.