Cleared Traditional

K844077 - NUTRIMIX EMPTY CONTAINER

K844077 is an FDA 510(k) clearance for NUTRIMIX EMPTY CONTAINER, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K844077 · Abbott Laboratories · General Hospital
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Feb 1985
Decision
119d
Days
Class 2
Risk

K844077 is an FDA 510(k) clearance for the NUTRIMIX EMPTY CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 15, 1985 after a review of 119 days - within the typical 510(k) review window.

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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K844077

510(k) Number K844077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1984
Decision Date February 15, 1985
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPE Device Classification - Class 2, Special Controls

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 43
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K844077.
BAG DECANTER
K852777 · Advance Medical Designs, Inc. · Aug 1985
BOTTLE DECANTER
K852778 · Advance Medical Designs, Inc. · Aug 1985
EMPTY SOLUTION TRANSFER CONTAINER
K850035 · The Healthcare Group Laboratories, Inc. · Jun 1985
EMPTY SOLUTION TRANSFER CONTAINER
K842170 · The Healthcare Group Laboratories, Inc. · Oct 1984
CAT 3040
K830193 · Burron Medical Products, Inc. · Mar 1983
DELMED IV CONTAINER
K830450 · Delmed, Inc. · Mar 1983