Cleared Traditional

K062482 - VENTED VIAL ADAPTER TRANSFER DEVICE

K062482 is the FDA 510(k) clearance for VENTED VIAL ADAPTER 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 71-day FDA review.

K062482 · Medimop Medical Projects, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
71d
Days
Class 2
Risk

K062482 is an FDA 510(k) clearance for the VENTED VIAL ADAPTER TRANSFER DEVICE. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Medimop Medical Projects, Ltd. (Raanana, IL). The FDA issued a Cleared decision on November 3, 2006 after a review of 71 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 K062482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2006
Decision Date November 03, 2006
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 K062482.
MEDLINE VIAL DECANTER
K111577 · Medline Industries, Inc. · Sep 2011
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
K100640 · B.Braun Medical, Inc. · Jul 2010
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
K090905 · B.Braun Medical, Inc. · Apr 2009
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
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