Cleared Traditional

NUTRIMIX EMPTY CONTAINER (K844077) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 29
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K844077.
EMPTY VIAFLEX PLASTIC CONTAINER
K922214 · Baxter Healthcare Corp · Mar 1993
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · Abbott Laboratories · Dec 1989
NUTRIMIX EMPTY CONTAINER
K860042 · Abbott Laboratories · Apr 1986
LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN
K791774 · Abbott Laboratories · Oct 1979
ADDITIVE HINGE CAP
K791796 · Abbott Laboratories · Oct 1979
LIFECARE EMPTY CONTAINER
K771228 · Abbott Laboratories · Aug 1977