# K101907: Haemonetics Cell Saver Elite Autotransfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Haemonetics Corp.
- Decided: Dec 3, 2010 after 148 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K932890 (1994). 2 ancestors in all.
4 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)
- K014083: Haemonetics Cell Saver 5 Autologous Blood Recovery System, Haemonetics Corp. (2002) Summary page 1.

## Most influential descendants
- 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
- Oct 21, 2019 · Class II · Z-0895-2020: Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long em
- Oct 21, 2019 · Class II · Z-0892-2020: Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long em
- Oct 21, 2019 · Class II · Z-0893-2020: Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long em
- Oct 21, 2019 · Class II · Z-0894-2020: Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long em
- Oct 21, 2019 · Class II · Z-0896-2020: Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long em
- Aug 2, 2017 · Class II · Z-0779-2019: Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.

## Indications for use
The Haemonetics Cell Saver® EliteTM 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 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.

Source page: https://510kreport.com/device/K101907
Methodology: https://510kreport.com/methodology