# K021927: Platelet Concentrate Separation Kit for Celsep Centrifuge System

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jul 12, 2002 after 30 days
- Product code: LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use)
- Device class: 1
- Regulation: 21 CFR 862.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K994148 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994148: 3I Model (S)7426 and 7427 Celsep Centrifuge System, Implant Innovations, Inc. (2000) Summary page 1.

## Most influential descendants
- K030555: GPS Platelet Separation Kit with Anticoagulant Acd-a (2003), 0 descendants of its own

## Indications for use
The Platelet Concentrate Separation kit is designed for use in the clinical laboratory or intra-operatively at point of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate fiom a small sample (50-60 rnl) of whole blood. The plasma and ancentrated platelets can be used for diagnostic tests.

Source page: https://510kreport.com/device/K021927
Methodology: https://510kreport.com/methodology