Cleared Traditional

K140730 - VIAL2BAG DIRECT CONNECT

K140730 is the FDA 510(k) clearance for VIAL2BAG DIRECT CONNECT by Medimop Medical Projects, Ltd.. It is a Class 2 General Hospital device (product code LHI) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K140730 · Medimop Medical Projects, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
80d
Days
Class 2
Risk

K140730 is an FDA 510(k) clearance for the VIAL2BAG DIRECT CONNECT. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Medimop Medical Projects, Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on June 12, 2014 after a review of 80 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 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 Medimop Medical Projects, Ltd. devices

Submission Details

510(k) Number K140730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2014
Decision Date June 12, 2014
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K140730.
Guarded Luer Connector
K173577 · International Medical Industries, Inc. · Jun 2018
APEX Compounding System Transfer Set
K151423 · B.Braun Medical, Inc. · Feb 2016
Universal Spike
K150787 · B.Braun Medical, Inc. · Dec 2015
DUAL SPIKE TRANSFER DEVICE
K120150 · B.Braun Medical, Inc. · May 2012
MEDLINE VIAL DECANTER
K111577 · Medline Industries, Inc. · Sep 2011
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
K100640 · B.Braun Medical, Inc. · Jul 2010