Cleared Traditional

K843954 - MIXING CONTAINER

K843954 is an FDA 510(k) clearance for MIXING CONTAINER, manufactured by American Mcgaw. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K843954 · American Mcgaw · General Hospital
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Nov 1984
Decision
50d
Days
Class 2
Risk

K843954 is an FDA 510(k) clearance for the MIXING CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by American Mcgaw (Santa Ana, US). The FDA issued a Cleared decision on November 28, 1984 after a review of 50 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.

View all American Mcgaw devices

FDA 510(k) Submission Details - K843954

510(k) Number K843954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1984
Decision Date November 28, 1984
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 K843954.
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
CAT 3040
K830193 · Burron Medical Products, Inc. · Mar 1983