Cleared Traditional

K844664 - THE I.V. BAG

K844664 is the FDA 510(k) clearance for THE I.V. BAG by Kabivitrum, Inc.. It is a Class 2 General Hospital device (product code KPE) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K844664 · Kabivitrum, Inc. · General Hospital
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May 1985
Decision
157d
Days
Class 2
Risk

K844664 is an FDA 510(k) clearance for the THE I.V. BAG. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Kabivitrum, Inc. (Berkeley, US). The FDA issued a Cleared decision on May 6, 1985 after a review of 157 days - an extended review 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: 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 Kabivitrum, Inc. devices

Submission Details

510(k) Number K844664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date May 06, 1985
Days to Decision 157 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
28d slower than avg
Panel avg: 129d · This submission: 157d
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 35
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K844664.
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · Abbott Laboratories · Dec 1989
CHURCHILL PARENTERAL NUTRITION BAG - EVA
K870395 · Churchill Corp. · Oct 1987
NUTRIMIX EMPTY CONTAINER
K860042 · Abbott Laboratories · Apr 1986
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