Cleared Traditional

K863204 - DEKA JR.

K863204 is an FDA 510(k) clearance for DEKA JR., manufactured by Deka Research & Development Corp.. The device is a Class 2 General Hospital device with product code LDR cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K863204 · Deka Research & Development Corp. · General Hospital
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Sep 1986
Decision
15d
Days
Class 2
Risk

K863204 is an FDA 510(k) clearance for the DEKA JR.. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on September 3, 1986 after a review of 15 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Deka Research & Development Corp. devices

FDA 510(k) Submission Details - K863204

510(k) Number K863204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1986
Decision Date September 03, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
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 30
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