Cleared Traditional

K172631 - Arisure Dry Spike

K172631 is an FDA 510(k) clearance for Arisure Dry Spike, manufactured by Yukon Medical. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K172631 · Yukon Medical · General Hospital
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Sep 2017
Decision
28d
Days
Class 2
Risk

K172631 is an FDA 510(k) clearance for the Arisure Dry Spike. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Yukon Medical (Durham, US). The FDA issued a Cleared decision on September 29, 2017 after a review of 28 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 Yukon Medical devices

FDA 510(k) Submission Details - K172631

510(k) Number K172631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2017
Decision Date September 29, 2017
Days to Decision 28 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 79
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K172631.
Vial Adapter Ø20 mm
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K173577 · International Medical Industries, Inc. · Jun 2018
APEX Compounding System Transfer Set
K151423 · B.Braun Medical, Inc. · Feb 2016
Universal Spike
K150787 · B.Braun Medical, Inc. · Dec 2015
VIAL-MATE Adaptor
K142600 · Baxter Healthcare Corporation · Nov 2014