Cleared Traditional

K121613 - AGILIA INFUSION SYSTEM

K121613 is an FDA 510(k) clearance for AGILIA INFUSION SYSTEM, manufactured by Fresenius Kabi AG. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K121613 · Fresenius Kabi AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
334d
Days
Class 2
Risk

K121613 is an FDA 510(k) clearance for the AGILIA INFUSION SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Fresenius Kabi AG (Lake Zurich, US). The FDA issued a Cleared decision on May 1, 2013 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Fresenius Kabi AG devices

FDA 510(k) Submission Details - K121613

510(k) Number K121613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2012
Decision Date May 01, 2013
Days to Decision 334 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 129d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 460
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K121613.
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
K141789 · Hospira, Inc. · Jan 2015
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K141102 · Hospira, Inc. · Jul 2014
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
K133801 · Baxter Healthcare Corporation · May 2014
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
K111275 · Smiths Medical Asd, Inc. · Feb 2013
SYMBIQ INFUSION AND ADMINSTRATION SET
K110901 · Hospira, Inc. · Mar 2012
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
K100798 · Medrad, Inc. · Jun 2010