Cleared Traditional

Vial Adapter Ø20 mm (K190149) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190149 · Avenir Performance Europeenne Medical (Apem) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
259d
Days
Class 2
Risk

K190149 is an FDA 510(k) clearance for the Vial Adapter Ø20 mm. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Avenir Performance Europeenne Medical (Apem) (Château-Landon, FR). The FDA issued a Cleared decision on October 15, 2019 after a review of 259 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.

View all Avenir Performance Europeenne Medical (Apem) devices

Submission Details

510(k) Number K190149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2019
Decision Date October 15, 2019
Days to Decision 259 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
130d slower than avg
Panel avg: 129d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Technology Sciences Group, Inc.
Om V. Singh

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 205
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K190149.
Vial Adapter
K260301 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · Jun 2026
Medline Bag Decanter
K250345 · Medline Industries, LP · Oct 2025
FlowArt® Vial Access Device Vented
K251715 · Asset Medikal · Oct 2025
Medline Microtek C-Flo Bag Decanter, Sterile (2000S)
K251676 · Microtek Medical, LLC · Sep 2025
HyHub™ and HyHub™ Duo Vial Access Devices
K243404 · Takeda Pharmaceuticals · Jul 2025
Arisure® Closed Male Luer with Spike Adapter (YM060)
K240761 · Yukon Medical, LLC · Mar 2025