# K964375: Sysmex SE/Ram-1

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex Corp.
- Decided: Mar 13, 1997 after 132 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- 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 K912494 (1991). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936023: Sysmex SE-9000 Automated Hematology Analyzer, Toa Medical Electronics USA, Inc. (1994) Summary page 1.
- K912494: Sysmex (TM) R-3000 Automated Reticulocyte Analyzer, Toa Medical Electronics USA, Inc. (1991) Summary page 1.

## 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

## Indications for use
The SE/RAM-1 is an In Vitro device for whole blood cell analysis in clinical laboratories. The SE-9000 portion is intended for blood cell analysis; the RAM-1 portion is intended for automated reticulocyte analysis. The instrument is a screening device for identifying abnormal blood specimens. Medical technologists are responsible for final review of abnormal cells.

Source page: https://510kreport.com/device/K964375
Methodology: https://510kreport.com/methodology