Cleared Abbreviated

K072759 - VIAL2BAG

K072759 is the FDA 510(k) clearance for VIAL2BAG by Medimop Medical Projects, Ltd.. It is a Class 2 General Hospital device (product code LHI) cleared through the Abbreviated 510(k) pathway after a 76-day FDA review.

K072759 · Medimop Medical Projects, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
76d
Days
Class 2
Risk

K072759 is an FDA 510(k) clearance for the VIAL2BAG. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Medimop Medical Projects, Ltd. (Lionville, US). The FDA issued a Cleared decision on December 13, 2007 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medimop Medical Projects, Ltd. devices

Submission Details

510(k) Number K072759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2007
Decision Date December 13, 2007
Days to Decision 76 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 65
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K072759.
MEDLINE VIAL DECANTER
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20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
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K041222 · B.Braun Medical, Inc. · Oct 2004
BAXJECT II
K042410 · Baxter Healthcare Corp · Oct 2004
CHEMO DISPENSING PIN, MODEL 12495
K024239 · Abbott Laboratories · Jan 2003