Cleared Traditional

AMICUS Separator System (K192150) - FDA 510(k) Clearance

K192150 · Fresenius Kabi AG · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
96d
Days
-
Risk

K192150 is an FDA 510(k) clearance for the AMICUS Separator System. Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Fresenius Kabi AG (Bad Homburg, DE). The FDA issued a Cleared decision on November 13, 2019 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fresenius Kabi AG devices

Submission Details

510(k) Number K192150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2019
Decision Date November 13, 2019
Days to Decision 96 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 130d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Device Class -

Regulatory Consultant

Fenwal, Inc.
Aunica Jones

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LKN Separator, Automated, Blood Cell And Plasma, Therapeutic

Devices cleared under the same product code (LKN) and FDA review panel - the closest regulatory comparables to K192150.
Spectra Optia Apheresis System
K183081 · Terumobct, Inc. · Feb 2019
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
K180615 · Fresenius Kabi USA,Llc · Dec 2018
Spectra Optia Apheresis System
K181049 · Terumobct, Inc. · Nov 2018
Spectra Optia Apheresis System
K172590 · Terumobct, Inc. · Mar 2018
FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
K874607 · Organon Teknika Corp. · Jan 1988