Cleared Traditional

K031861 - MIX2VIAL TRANSFER DEVICE

K031861 is the FDA 510(k) clearance for MIX2VIAL TRANSFER DEVICE 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 43-day FDA review.

K031861 · Medimop Medical Projects, Ltd. · General Hospital
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Jul 2003
Decision
43d
Days
Class 2
Risk

K031861 is an FDA 510(k) clearance for the MIX2VIAL TRANSFER DEVICE. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Medimop Medical Projects, Ltd. (M.P. Misgav, IL). The FDA issued a Cleared decision on July 29, 2003 after a review of 43 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 K031861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date July 29, 2003
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
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 K031861.
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
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BAXJECT II
K042410 · Baxter Healthcare Corp · Oct 2004
CHEMO DISPENSING PIN, MODEL 12495
K024239 · Abbott Laboratories · Jan 2003
CHEMO-AIDE DISPENSING PIN
K003730 · Baxter Healthcare Corp · Dec 2000
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
K973654 · Baxter Healthcare Corp · Oct 1997