Cleared Traditional

K232316 - DEKA Infusion System

K232316 is an FDA 510(k) clearance for DEKA Infusion System, manufactured by Deka Research and Development. The device is a Class 2 General Hospital device with product code LDR cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K232316 · Deka Research and Development · General Hospital
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Mar 2024
Decision
211d
Days
Class 2
Risk

K232316 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 (Manchester, US). The FDA issued a Cleared decision on March 1, 2024 after a review of 211 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Deka Research and Development devices

FDA 510(k) Submission Details - K232316

510(k) Number K232316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2023
Decision Date March 01, 2024
Days to Decision 211 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 129d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDR Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LDR Controller, Infusion, Intravascular, Electronic

All 29
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K232316.
DEKA Infusion System, DEKA Administration Set
K242693 · Deka Research and Development Corporation · Oct 2024
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500
K971826 · Alexander Mfg. Co. · Jul 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P
K971865 · Alexander Mfg. Co. · Jul 1997
3M IV FLOW REGULATOR
K896907 · 3M Company · Feb 1990
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+
K894487 · Y · Sep 1989
LIFECARE 75 CONTROLLER
K893487 · Abbott Laboratories · Jul 1989