Cleared Traditional

K844664 - THE I.V. BAG

K844664 is an FDA 510(k) clearance for THE I.V. BAG, manufactured by Kabivitrum, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K844664

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.

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 57
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K844664.
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
NUTRIMIX EMPTY CONTAINER
K844077 · Abbott Laboratories · Feb 1985
EMPTY SOLUTION TRANSFER CONTAINER
K842170 · The Healthcare Group Laboratories, Inc. · Oct 1984
EMPTY SOLUTION TRANSFER CONTAINER 1000
K843523 · Polymer Technology Corp. · Oct 1984