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FDA 510(k)

DEKA Infusion System, DEKA Administration Set

K-Number: K242693 · 2024-10-07

ApplicantDeka Research and Development Corporation
Decision Date2024-10-07
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DEKA Infusion System, DEKA Administration Set is a medical device manufactured by Deka Research and Development Corporation. It received FDA 510(k) clearance on 2024-10-07 under approval number K242693. 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 2024-10-07. It is manufactured by Deka Research and Development Corporation. The 510(k) number is K242693.

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

DEKA Infusion System, DEKA Administration Set received FDA 510(k) clearance on 2024-10-07, under approval number K242693.

What company makes DEKA Infusion System, DEKA Administration Set?

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

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.

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Related PubMed Literature

PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) 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)

Related Devices (Code: LDR)

K153760Volumetric Infusion ControllerDEKA Research & Development K232316DEKA Infusion System, DEKA Administration SetDeka Research and Development

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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