Cleared Special

K160503 - Vented Vial Adapter Transfer Device - 13mm (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K160503 · Medimop Medical Projects, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
70d
Days
Class 2
Risk

K160503 is an FDA 510(k) clearance for the Vented Vial Adapter Transfer Device - 13mm. 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 May 4, 2016 after a review of 70 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medimop Medical Projects, Ltd. devices

Submission Details

510(k) Number K160503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2016
Decision Date May 04, 2016
Days to Decision 70 days
Submission Type Special
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: 128d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 204
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K160503.
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K243985 · Icu Medical, Inc. · Jan 2025