Cleared Traditional

K852893 - VIAL DECANTER

K852893 is the FDA 510(k) clearance for VIAL DECANTER by Advance Medical Designs, Inc.. It is a Class 2 General Hospital device (product code KPE) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K852893 · Advance Medical Designs, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
73d
Days
Class 2
Risk

K852893 is an FDA 510(k) clearance for the VIAL DECANTER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on September 20, 1985 after a review of 73 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 Advance Medical Designs, Inc. devices

Submission Details

510(k) Number K852893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1985
Decision Date September 20, 1985
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
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 K852893.
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