Cleared Special

K213089 - Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K213089 · Ivenix, Inc. · General Hospital
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Nov 2021
Decision
47d
Days
Class 2
Risk

K213089 is an FDA 510(k) clearance for the Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Ivenix, Inc. (North Andover, US). The FDA issued a Cleared decision on November 10, 2021 after a review of 47 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ivenix, Inc. devices

Submission Details

510(k) Number K213089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2021
Decision Date November 10, 2021
Days to Decision 47 days
Submission Type Special
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
81d faster than avg
Panel avg: 128d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 1173
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