# K953681: Haemonetics Therapeutic Plasma Exchange Set

- Pathway: 510(k) (Traditional)
- Applicant: Haemonetics Corp.
- Decided: Jun 4, 1996 after 302 days
- Product code: LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic)
- Device class: U
- 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 K900105 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900105: Cobe Spectra Blood Component Separator Therapeutic, Cobe Laboratories, Inc. (1991) Summary page 1.
- (no number) COBE Spectra™: named in the summary without a submission number

## Indications for use
TPE is performed using the Haemonetics MCS/MCS+ system to remove a significant quantity of platelet poor plasma and replace it with a solution as determined by the attending physician.

Source page: https://510kreport.com/device/K953681
Methodology: https://510kreport.com/methodology