Cleared Traditional

Ivenix Infusion System (IIS) (K183311) - FDA 510(k) Clearance

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

K183311 · Ivenix, Inc. · General Hospital
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Jun 2019
Decision
190d
Days
Class 2
Risk

K183311 is an FDA 510(k) clearance for the Ivenix Infusion System (IIS). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Ivenix, Inc. (North Andover, US). The FDA issued a Cleared decision on June 7, 2019 after a review of 190 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Ivenix, Inc. devices

Submission Details

510(k) Number K183311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2018
Decision Date June 07, 2019
Days to Decision 190 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
61d slower than avg
Panel avg: 129d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 235
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K183311.
FREEDOM Integrated Syringe Infusion System
K200176 · Repro-Med Systems, Inc. Dba Koru Medical Systems · Dec 2021
FreedomEdge(R) Syringe Infusion System
K211206 · Repro-Medical System, Inc., Dba Koru Medical Systems · Nov 2021
Sapphire Infusion Pump, Sapphire administration sets
K192860 · Q Core Medical , Ltd. · Nov 2020
Unity Subcutaneous Delivery System for Remodulin
K190182 · DEKA Research & Development · May 2019
Power Infuser
K172653 · ZOLL Medical Corporation · Jul 2018
Perfusor® Space Syringe Infusion Pump System
K172831 · B.Braun Medical, Inc. · Jun 2018