Cleared Traditional

K172884 - Arisure Closed Vial Adapter

K172884 is an FDA 510(k) clearance for Arisure Closed Vial Adapter, 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 12-day FDA review.

K172884 · Yukon Medical · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
12d
Days
Class 2
Risk

K172884 is an FDA 510(k) clearance for the Arisure Closed Vial Adapter. 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 October 3, 2017 after a review of 12 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.

FDA 510(k) Submission Details - K172884

510(k) Number K172884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2017
Decision Date October 03, 2017
Days to Decision 12 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 129d · This submission: 12d
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K172884.
Guarded Luer Connector
K173577 · International Medical Industries, Inc. · Jun 2018
GRI-FILL PERISTALTIC SET
K162216 · Laboratorios Grifols, S.A. · Oct 2017
Vial Adapter 15mm
K171796 · Medimop Medical Project , Ltd. · Oct 2017
Arisure Dry Spike
K172631 · Yukon Medical · Sep 2017
Vial2Bag Direct Connect
K170095 · Medimop Medical Project , Ltd. · Mar 2017
OnSite-IV
K161800 · Pharmc, LLC · Dec 2016

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.