# K993581: Haemonetics LN 193 Disposable Set, for Use with the Haemonetics Cellsever Haemolite 2 Family of Autologous Blood Recover

- Pathway: 510(k) (Special)
- Applicant: Haemonetics Corp.
- Decided: Nov 18, 1999 after 27 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 K883934 (1988). 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)
- K883934: Cell Saver Haemolite B Auto. Blood Recovery System, Haemonetics Corp. (1988) Summary page 1.

## Indications for use
To be used with the Haemonetics Cell Saver Haemolite 2 family of autologous blood recovery systems to collect, concentrate, and wash red blood cells from diluted intraoperative and post-operative sned blood for autotransfusion.

Source page: https://510kreport.com/device/K993581
Methodology: https://510kreport.com/methodology