Cleared Traditional

K162462 - AMICUS Separator System, AMICUS Separator System (FDA 510(k) Clearance)

Also includes:
Refurbished

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

K162462 · Fresenius Kabi USA,Llc · Hematology device
Nov 2016
Decision
82d
Days
Class 2
Risk

K162462 is an FDA 510(k) clearance for the AMICUS Separator System, AMICUS Separator System. Classified as Separator, Automated, Blood Cell, Diagnostic (product code GKT), Class II - Special Controls.

Submitted by Fresenius Kabi USA,Llc (Lake Zurich, US). The FDA issued a Cleared decision on November 23, 2016 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9245 - the FDA hematology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K162462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2016
Decision Date November 23, 2016
Days to Decision 82 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 205d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKT Separator, Automated, Blood Cell, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9245
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 Hematology devices follow this clearance model.