# K960734: Haemocell System 350 or S350

- Pathway: 510(k) (Traditional)
- Applicant: Haemocell Plc
- Decided: Dec 10, 1996 after 292 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: 1 generation back to K861677 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914053: System 350, Stryker Corp. (1992) Summary page 2.
- K861677: Pharmaseal Medi-Vac Intra-Oper. Autotransfus. Kit, American Pharmaseal Div. Ahsc (1986) Summary page 2.

## Indications for use
The Haemocell System 350 is an autologous transfusion system designed to collect blood during or after an elective or emergency surgical procedure, filter the blood, process as required by the physician, and reinfuse the autologous blood. The Haemocell System 350 is designed to be used in accordance with the American Association of Blood Banks, Guidelines for Blood Salvage and Reinfusion in Surgery and Trauma (1993). No change to the intended use of the System 350 is proposed as compared to the predicate devices.

Source page: https://510kreport.com/device/K960734
Methodology: https://510kreport.com/methodology