Cleared Traditional

MODIFIED EVA-MIX AND DI-MIX BAGS (K880506) - FDA 510(k) Clearance

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

K880506 · Gil-Med Industries C/O Kegan & Kegan, Ltd. · General Hospital
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May 1988
Decision
102d
Days
Class 2
Risk

K880506 is an FDA 510(k) clearance for the MODIFIED EVA-MIX AND DI-MIX BAGS. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Gil-Med Industries C/O Kegan & Kegan, Ltd. (Chicago, US). The FDA issued a Cleared decision on May 20, 1988 after a review of 102 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 Gil-Med Industries C/O Kegan & Kegan, Ltd. devices

Submission Details

510(k) Number K880506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1988
Decision Date May 20, 1988
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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 28
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K880506.
UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET
K932477 · Baxter Healthcare Corp · Jun 1994
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
NUTRIMIX EMPTY CONTAINER
K844077 · Abbott Laboratories · Feb 1985
LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN
K791774 · Abbott Laboratories · Oct 1979