# K983022: Smartcell Processing System

- Pathway: 510(k) (Traditional)
- Applicant: Harvest Technologies, LLC
- Decided: Apr 2, 1999 after 214 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Haemonetics Cell Saver 5 Autotransfusion System: named in the summary without a submission number

## Indications for use
The SmartCell™ Processing System is indicated for the processing of autologous shed blood collected intraoperatively or postoperatively to obtain concentrated red blood cells for reinfusion

Source page: https://510kreport.com/device/K983022
Methodology: https://510kreport.com/methodology