RESPCARE FACE MASK— 510(k) K052227

Substantially Equivalent

Respcare, Inc.

FDA 510(k) clearance K052227 for RESPCARE FACE MASK, Substantially Equivalent on 2005-10-28. Applicant: Respcare, Inc..

Clearance details

Applicant: Respcare, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2005-08-16
Decision date: 2005-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coconut Creek, FL, US

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.