Cleared Traditional

K080976 - NEXUS I.V. FLUID TRANSFER DEVICE (FDA 510(k) Clearance)

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

K080976 · Nexus Medical, LLC · General Hospital
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Nov 2008
Decision
217d
Days
Class 2
Risk

K080976 is an FDA 510(k) clearance for the NEXUS I.V. FLUID TRANSFER DEVICE. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Nexus Medical, LLC (Lenexa, US). The FDA issued a Cleared decision on November 10, 2008 after a review of 217 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 Nexus Medical, LLC devices

Submission Details

510(k) Number K080976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2008
Decision Date November 10, 2008
Days to Decision 217 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
89d slower than avg
Panel avg: 128d · This submission: 217d
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 204
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