BD Alaris Pump Epidural Infusion Set— 510(k) K221319

Name: FDA 510(k) clearance K221319
Creator: U.S. Food and Drug Administration
Published: 2023-07-21

Substantially Equivalent

Care Fusion

FDA 510(k) clearance K221319 for BD Alaris Pump Epidural Infusion Set, Substantially Equivalent on 2023-07-21. Applicant: Care Fusion. Device class: 2.

Clearance details

Applicant: Care Fusion
Product code: Code PWH
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2022-05-06
Decision date: 2023-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PWH

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K211649 — PCEA Syringe Set2021-11-23
K172592 — CADD Yellow High Volume Administration Set with NRFit connector2018-05-17
K162219 — CADD® Infusion Disposables Portfolio with NRFit connectors2017-07-20

More clearances from Care Fusion

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K233021 — BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device2024-03-06
K231888 — BD Texium Needle-Free Syringe2023-09-25
K221327 — BD Alaris Pump Infusion Sets2023-07-21
K223101 — BD Secondary Infusion Set2023-05-12
K223088 — BD SmartSite Needle-Free Connector2023-04-07

Adverse events under product code PWH

product code PWH

Other: 1
Total: 1

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.