> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Firm Selling Unapproved Ycellbio Kit
- URL: https://www.fdaweb.com/firm-selling-unapproved-ycellbio-kit/
- Published: 2018-07-24T12:00:00.000Z
- Updated: 2026-09-15T00:21:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141940

FDA says Ycellbio Medical Co., Seoul, South Korea, is selling its Y-PRP System (Ycellbio kit) without an approved PMA or IDE in place. A 7/10 [Notice of Violation](https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/UCM613771.pdf?ref=fdaweb.com) says that promotional materials claim that the kit “facilitates separating and harvesting ‘pure sources of concentrated platelets’” from “a small sample of blood at a patient’s point of care.”

The letter notes that on 3/23/16 the agency notified the firm that the kit is not substantially equivalent to devices marketed in interstate commerce as of the enactment date of the Medical Device Amendments or to any device that has been reclassified into either Class 1 or Class 2 or to another device found to be substantially equivalent through the 510(k) process.

Although the FDA database does not list premarket approval clearance for the company’s Class 3 device, the letter says, the kit appears to be available for purchase worldwide, including to U.S. buyers.

The letter also notes that the company’s product brochure contains the FDA logo, which is not to be used on private sector materials.