# K221722: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)

- Pathway: 510(k) (Traditional)
- Applicant: Haemonetics Corporation
- Decided: Nov 15, 2022 after 154 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K932890 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162423: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System, Haemonetics Corporation (2017) Summary page 4.

## Indications for use
The Haemonetics® Cell Saver® Elite/Elite®+ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping the processed red blood cells to a product bag. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within the recommended time guidelines of the American Association of Blood Banks (AABB), 9th Edition.

Source page: https://510kreport.com/device/K221722
Methodology: https://510kreport.com/methodology