Cleared Traditional

K843523 - EMPTY SOLUTION TRANSFER CONTAINER 1000

K843523 is an FDA 510(k) clearance for EMPTY SOLUTION TRANSFER CONTAINER 1000, manufactured by Polymer Technology Corp.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K843523 · Polymer Technology Corp. · General Hospital
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Oct 1984
Decision
39d
Days
Class 2
Risk

K843523 is an FDA 510(k) clearance for the EMPTY SOLUTION TRANSFER CONTAINER 1000. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Polymer Technology Corp. (Whitwater, US). The FDA issued a Cleared decision on October 16, 1984 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K843523

510(k) Number K843523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1984
Decision Date October 16, 1984
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 116
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K843523.
NUTRIBAG MIXING CONTAINER -2000 ML
K844410 · Medical & Pharmaceutical Supplies, Inc. · Nov 1984
GIL-MED PARENTERAL NUTRITION OR MEDICINE
K841597 · Gil-Med Industries C/O Kegan & Kegan, Ltd. · Oct 1984
EMPTY SOLUTION TRANSFER CONTAINER
K842170 · The Healthcare Group Laboratories, Inc. · Oct 1984
HOME NUTRIBAG MIXING CONTAINER 1000ML
K842628 · Medical & Pharmaceutical Supplies, Inc. · Sep 1984
HOME NUTRIBAG MIXING CONTAINER 3000ML
K842629 · Medical & Pharmaceutical Supplies, Inc. · Sep 1984
DIMIX CONTAINER FOR PARNETERAL NUTRIT
K840915 · Gil-Med Industries C/O Kegan & Kegan, Ltd. · Apr 1984
K843523 · EMPTY SOLUTION TRANSFER CONTAINER 1000
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