# K950508: Sysmex SF-3000

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex Corp.
- Decided: Nov 3, 1995 after 270 days
- Product code: FPK (Tubing, Fluid Delivery)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992875: Sysmex XE-2100, Automatated Hematology Analyzer (1999), 7 descendants of its own
- K061616: Coulter LH 780 Hematology Analyzer (2006), 1 descendant of its own
- K050719: Abx Pentra DX 120: Option SPS Evolution (2005), 1 descendant of its own
- K160429: BC-5390 Auto Hematology Analyzer (2016), 0 descendants of its own
- K151133: Pentra XLR (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K950508
Methodology: https://510kreport.com/methodology