Cleared Special

K183205 - PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System

K183205 is an FDA 510(k) clearance for PureBMC SupraPhysiologic Concentrating ..., manufactured by Emcyte Corporation. The device is a Class 1 Hematology device with product code JQC cleared through the Special 510(k) pathway after a 192-day FDA review.

K183205 · Emcyte Corporation · Hematology device
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May 2019
Decision
192d
Days
Class 1
Risk

K183205 is an FDA 510(k) clearance for the PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhys.... Classified as Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (product code JQC), Class I - General Controls.

Submitted by Emcyte Corporation (Fort Meyers, US). The FDA issued a Cleared decision on May 30, 2019 after a review of 192 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2050 - the FDA hematology 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K183205

510(k) Number K183205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 19, 2018
Decision Date May 30, 2019
Days to Decision 192 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 113d · This submission: 192d
Pathway characteristics
Modification to existing cleared device.

JQC Device Classification - Class 1, General Controls

Product Code JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

All 36
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K183205 · PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
Download PDF Emcyte Corporation