# K932890: Cell Saver 5 System

- Pathway: 510(k) (Traditional)
- Applicant: Haemonetics Corp.
- Decided: Jan 5, 1994 after 205 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K014083: Haemonetics Cell Saver 5 Autologous Blood Recovery System (2002), 5 descendants of its own
- 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

## Recalls of this device
- Oct 21, 2019 · Class II · Z-0886-2020: 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-0887-2020: 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-0888-2020: 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-0891-2020: 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-0885-2020: 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-0889-2020: 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-0890-2020: 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
- Dec 17, 2002 · Not classified · Z-0498-03: Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Dec 17, 2002 · Not classified · Z-0499-03: Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Dec 17, 2002 · Not classified · Z-0501-03: Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Dec 17, 2002 · Not classified · Z-0500-03: Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Dec 17, 2002 · Not classified · Z-0502-03: Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Dec 17, 2002 · Not classified · Z-0503-03: Disposable Set for Autologous Blood recovery may leak saline at the Y-connector

Source page: https://510kreport.com/device/K932890
Methodology: https://510kreport.com/methodology