Cleared Traditional

K130179 - MP VIAL ADAPTER 13MM

K130179 is an FDA 510(k) clearance for MP VIAL ADAPTER 13MM, manufactured by Medimop Medical Projects, Ltd.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K130179 · Medimop Medical Projects, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
195d
Days
Class 2
Risk

K130179 is an FDA 510(k) clearance for the MP VIAL ADAPTER 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 August 8, 2013 after a review of 195 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K130179

510(k) Number K130179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2013
Decision Date August 08, 2013
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 129d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

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 189
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K130179.
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K131646 · Shanghai Jinta Medical Co., Ltd. · Nov 2013
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K132863 · Yukon Medical, LLC · Oct 2013
VIAL CONNECTOR 13MM CLOSED COLLAR
K132040 · Medimop Medical Projects, Ltd. · Jul 2013
PROTECTOR, INJECTOR, CONNECTOR
K120384 · Bd Medical-Medical Surgical Systems · Sep 2012
VIALOK SINGLE VIAL ACCESS DEVICE VENTED
K122265 · Yukon Medical, LLC · Aug 2012
K130179 · MP VIAL ADAPTER 13MM
Download PDF FDA Summary Medimop Medical Proje…