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FDA 510(k)

DEKA Infusion System, DEKA Administration Set

K-Number: K232316 · 2024-03-01

ApplicantDeka Research and Development
Decision Date2024-03-01
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DEKA Infusion System, DEKA Administration Set is a medical device manufactured by Deka Research and Development. It received FDA 510(k) clearance on 2024-03-01 under approval number K232316. The device is classified under product code LDR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEKA Infusion System, DEKA Administration Set?

DEKA Infusion System, DEKA Administration Set is a medical device that received FDA 510(k) clearance on 2024-03-01. It is manufactured by Deka Research and Development. The 510(k) number is K232316.

When was DEKA Infusion System, DEKA Administration Set approved by the FDA?

DEKA Infusion System, DEKA Administration Set received FDA 510(k) clearance on 2024-03-01, under approval number K232316.

What company makes DEKA Infusion System, DEKA Administration Set?

DEKA Infusion System, DEKA Administration Set is manufactured by Deka Research and Development.

What is the FDA product code for DEKA Infusion System, DEKA Administration Set?

The FDA product code for DEKA Infusion System, DEKA Administration Set is LDR.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39382899 US FDA Advisory Panel Members' Assessment of Premarket Approval Process and Suggestions for Improvement. JAMA network open (2024) PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024) PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024)

Other Devices by Deka Research and Development

K202690Remunity Pump for Remodulin (treprostinil) Injection K213536DEKA ACE Pump System K240920HemoCare Bicarbonate Concentrate Set (BCS) K233557HemoCare Hemodialysis System K240256Remunity System K241178DEKA ACE Pump System

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Related Devices (Code: LDR)

K153760Volumetric Infusion ControllerDEKA Research & Development K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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