Cleared Traditional

K201415 - Vial2Bag Advanced 20mm Admixture Device

K201415 is an FDA 510(k) clearance for Vial2Bag Advanced 20mm Admixture Device, manufactured by West Pharmaceutical Services Az, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K201415 · West Pharmaceutical Services Az, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
145d
Days
Class 2
Risk

K201415 is an FDA 510(k) clearance for the Vial2Bag Advanced 20mm Admixture Device. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by West Pharmaceutical Services Az, Inc. (Scottsdale, US). The FDA issued a Cleared decision on October 21, 2020 after a review of 145 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. 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.

View all West Pharmaceutical Services Az, Inc. devices

FDA 510(k) Submission Details - K201415

510(k) Number K201415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2020
Decision Date October 21, 2020
Days to Decision 145 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
16d slower than avg
Panel avg: 129d · This submission: 145d
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 Consultant

West Pharmaceutical Services, Inc.
Di Wu

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 73
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K201415.
B Dispensing Line
K203674 · Aea Srl · Sep 2021
ProntoPump Sterile Tube Set
K200893 · Ipax, Inc. · May 2021
Mini Spike Plus 6/8R
K201469 · B.Braun Medical, Inc. · Dec 2020
Rio Vial-to-Bag Drug Reconstitution Device
K192154 · Icu Medical · Apr 2020
Decanting Device
K182819 · Gcmedica Enterprise Ltd.(Wuxi) · Dec 2019
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
K190816 · Avenir Performance Europeenne Medical (Apem) · Nov 2019