SmartCell Processing System
510(k) K983022
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983022 | Date2 Apr 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CAC
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5830
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SmartCell Processing System is an Apparatus, Autotransfusion designed for concentrating autologous shed blood for reinfusion. It processes blood components to recover red blood cells, platelets, and plasma from intraoperative or postoperative blood loss, enabling safe return to the patient. The system leverages centrifugation and filtration to isolate viable cells while removing contaminants, reducing transfusion requirements and supporting autologous blood recovery protocols.
The system consists of reusable SC-1000 hardware paired with sterile, single-use SCP-1500 Process Packs. It is intended for use in operating rooms, surgical suites, or blood banks under sterile conditions. The device is classified as Class II under FDA regulation 868.5830 and holds a FDA 510(k) clearance (K983022) for substantial equivalence. Storage and handling follow manufacturer guidelines to maintain sterility and functionality, with no MRI safety restrictions specified.
Other devices from Harvest Technologies, Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the SmartCell Processing System used for?
The SmartCell Processing System is designed to concentrate autologous shed blood—blood lost during surgery or after an operation—so it can be safely returned to the patient. It isolates viable red blood cells, platelets, and plasma while removing contaminants, helping to minimize the need for allogeneic transfusions and supporting autologous blood recovery protocols in operating rooms, surgical suites, or blood banks.
How is the SmartCell Processing System supplied?
The system consists of reusable hardware called the SC-1000 paired with sterile, single-use SCP-1500 Process Packs. The reusable components ensure durability and efficiency, while the single-use packs maintain sterility and reduce cross-contamination risks between patients.
Is the SmartCell Processing System sterile?
Yes, the SmartCell Processing System is intended for use under sterile conditions. The single-use SCP-1500 Process Packs are sterile, and the reusable SC-1000 hardware must be cleaned and maintained according to manufacturer guidelines to preserve sterility and functionality.
Can the SmartCell Processing System be reused?
The SC-1000 hardware is reusable, but it requires proper cleaning, maintenance, and sterilization between uses to ensure safety and performance. The SCP-1500 Process Packs, however, are designed for single-use only to maintain sterility and prevent contamination.
How should the SmartCell Processing System be stored?
The reusable SC-1000 hardware should be stored in a clean, dry environment following the manufacturer’s instructions to prevent damage or contamination. Single-use SCP-1500 Process Packs should be stored according to their packaging guidelines, typically in a cool, dry place away from direct sunlight until use.