SAFERSLEEP SYSTEM— 510(k) K050883

Substantially Equivalent

Safer Sleep, LLC

FDA 510(k) clearance K050883 for SAFERSLEEP SYSTEM, Substantially Equivalent on 2005-11-04. Applicant: Safer Sleep, LLC.

Clearance details

Applicant: Safer Sleep, LLC
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 2005-04-07
Decision date: 2005-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.