Cleared Traditional

FlowArt Valve for Vial Access (K232987) - FDA 510(k) Clearance

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

K232987 · Asset Medikal Tasarim Sanayi VE Ticaret A.S. · General Hospital
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Jun 2024
Decision
278d
Days
Class 2
Risk

K232987 is an FDA 510(k) clearance for the FlowArt Valve for Vial Access. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Asset Medikal Tasarim Sanayi VE Ticaret A.S. (Istanbul, TR). The FDA issued a Cleared decision on June 26, 2024 after a review of 278 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 Asset Medikal Tasarim Sanayi VE Ticaret A.S. devices

Submission Details

510(k) Number K232987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2023
Decision Date June 26, 2024
Days to Decision 278 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 129d · This submission: 278d
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 Peers - LHI Set, I.v. Fluid Transfer

All 64
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K232987.
SmartSiteTM Vented Vial Access Device
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K233284 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · May 2024
nextaro® v, 20/20
K240748 · Sfm Medical Devices GmbH · Apr 2024