# K014083: Haemonetics Cell Saver 5 Autologous Blood Recovery System

- Pathway: 510(k) (Special)
- Applicant: Haemonetics Corp.
- Decided: Jan 8, 2002 after 28 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932890 (1994). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932890: Cell Saver 5 System, Haemonetics Corp. (1994) Summary page 1.
- (no number) LN246 10L Waste Bag: named in the summary without a submission number

## Most influential descendants
- K101907: Haemonetics Cell Saver Elite Autotransfusion System (2010), 4 descendants of its own
- K120586: Cell Saver Elite (2012), 3 descendants of its own
- K160197: Haemonetics Cell Saver Elite Autotransfusion System (2016), 2 descendants of its own
- K162423: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (2017), 1 descendant of its own
- K221722: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (2022), 0 descendants of its own

## Recalls of this device
- Aug 2, 2017 · Class II · Z-0778-2019: Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
- Dec 21, 2005 · Not classified · Z-0822-06: Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard
- Dec 21, 2005 · Not classified · Z-0823-06: Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard

## Indications for use
The Cell Saver 5 Autologous Blood Recovery System is 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 this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection. The LN291A is intended to be used with the CS5 Autologous Blood Recovery System for cell salvage protocols. The LN242 is intended to be used with the CS5 Autologous Blood Recovery System as a replacement waste bag.

Source page: https://510kreport.com/device/K014083
Methodology: https://510kreport.com/methodology