510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K021927Substantially Equivalent

Platelet Concentrate Separation Kit for Celsep Centrifuge System

Zimmer GmbH, Warsaw IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021927 is the FDA 510(k) clearance record for PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM, a class I device, cleared for Biomet, Inc. on under FDA product code LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K021927.

Clearance record

Decision date
Received
(30 days to decision)
Product code
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Biomet, Inc. 56 E Bell Dr., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LXG

Trailing 12 months

FDA records hold no clearances under product code LXG in the trailing twelve months.

FDA records show no clearances under product code LXG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LXG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260