Cleared Special

K242693 - DEKA Infusion System, DEKA Administration Set (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K242693 · Deka Research and Development Corporation · General Hospital
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Oct 2024
Decision
28d
Days
Class 2
Risk

K242693 is an FDA 510(k) clearance for the DEKA Infusion System, DEKA Administration Set. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Deka Research and Development Corporation (Manchester, US). The FDA issued a Cleared decision on October 7, 2024 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Deka Research and Development Corporation devices

Submission Details

510(k) Number K242693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2024
Decision Date October 07, 2024
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 128d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LDR Controller, Infusion, Intravascular, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.