# K994148: 3I Model (S)7426 and 7427 Celsep Centrifuge System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Feb 1, 2000 after 55 days
- Product code: JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Predicate Centrifuge: named in the summary without a submission number

## Most influential descendants
- K021927: Platelet Concentrate Separation Kit for Celsep Centrifuge System (2002), 1 descendant of its own
- K030340: Autologel Process Centrifuge, Model B4360 (100-103, 100-129) (2003), 0 descendants of its own
- K030555: GPS Platelet Separation Kit with Anticoagulant Acd-a (2003), 0 descendants of its own

## Indications for use
The 3i “CelSep” Centrifuge System, 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 from a small sample (50-60ml) of whole blood. The plasma and concentrated platelets produced can be used for diagnostic tests.

Source page: https://510kreport.com/device/K994148
Methodology: https://510kreport.com/methodology