SAFERSLEEP SYSTEM— 510(k) K050883

Name: FDA 510(k) clearance K050883
Creator: U.S. Food and Drug Administration
Published: 2005-11-04

Substantially Equivalent

Safer Sleep, LLC

FDA 510(k) clearance K050883 for SAFERSLEEP SYSTEM, Substantially Equivalent on 2005-11-04. Applicant: Safer Sleep, LLC. Device class: 2.

Clearance details

Applicant: Safer Sleep, LLC
Product code: Code BSZ
Device class: Class 2
Regulation: 21 CFR 868.5160
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 ↗

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K253330 — A5 Anesthesia System (A5); A7 Anesthesia System (A7)2026-06-25
K252746 — Atlan (4 models)2026-05-21
K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features) +1 more2025-07-11
K230931 — Atlan2023-07-23
K213867 — Carestation 750/750c2023-03-28

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.