Cleared Traditional

K860042 - NUTRIMIX EMPTY CONTAINER

K860042 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 93-day FDA review.

K860042 · Abbott Laboratories · General Hospital
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Apr 1986
Decision
93d
Days
Class 2
Risk

K860042 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 April 9, 1986 after a review of 93 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 - K860042

510(k) Number K860042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date April 09, 1986
Days to Decision 93 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
36d faster than avg
Panel avg: 129d · This submission: 93d
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 K860042.
EMPTY VIAFLEX PLASTIC CONTAINER
K922214 · Baxter Healthcare Corp · Mar 1993
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · Abbott Laboratories · Dec 1989
CHURCHILL PARENTERAL NUTRITION BAG - EVA
K870395 · Churchill Corp. · Oct 1987
VIAL DECANTER
K852893 · Advance Medical Designs, Inc. · Sep 1985
BAG DECANTER
K852777 · Advance Medical Designs, Inc. · Aug 1985
BOTTLE DECANTER
K852778 · Advance Medical Designs, Inc. · Aug 1985