Cleared Special

K171796 - Vial Adapter 15mm

K171796 is an FDA 510(k) clearance for Vial Adapter 15mm, manufactured by Medimop Medical Project , Ltd.. The device is a Class 2 General Hospital device with product code LHI cleared through the Special 510(k) pathway after a 118-day FDA review.

K171796 · Medimop Medical Project , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
118d
Days
Class 2
Risk

K171796 is an FDA 510(k) clearance for the Vial Adapter 15mm. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Medimop Medical Project , Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on October 12, 2017 after a review of 118 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K171796

510(k) Number K171796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2017
Decision Date October 12, 2017
Days to Decision 118 days
Submission Type Special
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
11d faster than avg
Panel avg: 129d · This submission: 118d
Pathway characteristics
Modification to existing cleared device.

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 169
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K171796.
nextaro Transfer System, nextaro va
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