Cleared Traditional

INFUSION IV SET (K001879) - FDA 510(k) Clearance

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

K001879 · Nirvi Intl. USA · General & Plastic Surgery device
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Nov 2001
Decision
518d
Days
Class 2
Risk

K001879 is an FDA 510(k) clearance for the INFUSION IV SET. Classified as I.v. Start Kit (product code LRS), Class II - Special Controls.

Submitted by Nirvi Intl. USA (Pittsburg, US). The FDA issued a Cleared decision on November 20, 2001 after a review of 518 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5200 - the FDA general and plastic surgery 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Nirvi Intl. USA devices

Submission Details

510(k) Number K001879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2000
Decision Date November 20, 2001
Days to Decision 518 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
403d slower than avg
Panel avg: 115d · This submission: 518d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRS I.v. Start Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 & Plastic Surgery devices follow this clearance model.