Cleared Traditional

K840915 - DIMIX CONTAINER FOR PARNETERAL NUTRIT

K840915 is the FDA 510(k) clearance for DIMIX CONTAINER FOR PARNETERAL NUTRIT by Gil-Med Industries C/O Kegan & Kegan, Ltd.. It is a Class 2 General Hospital device (product code KPE) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K840915 · Gil-Med Industries C/O Kegan & Kegan, Ltd. · General Hospital
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Apr 1984
Decision
48d
Days
Class 2
Risk

K840915 is an FDA 510(k) clearance for the DIMIX CONTAINER FOR PARNETERAL NUTRIT. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Gil-Med Industries C/O Kegan & Kegan, Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - 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 Gil-Med Industries C/O Kegan & Kegan, Ltd. devices

Submission Details

510(k) Number K840915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1984
Decision Date April 17, 1984
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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 - KPE Container, I.v.

All 39
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K840915.
BAG DECANTER
K852777 · Advance Medical Designs, Inc. · Aug 1985
BOTTLE DECANTER
K852778 · Advance Medical Designs, Inc. · Aug 1985
NUTRIMIX EMPTY CONTAINER
K844077 · Abbott Laboratories · Feb 1985
CAT 3040
K830193 · Burron Medical Products, Inc. · Mar 1983
TOTAL PARENTERAL NUTRITION SET BAG
K801652 · Cutter Laboratories, Inc. · Aug 1980
LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN
K791774 · Abbott Laboratories · Oct 1979