# K964946: Sysmex CA-1000/Sysmex CA-5000

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex Corp.
- Decided: Mar 18, 1997 after 98 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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 K931149 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931149: CA-1000 Automated Coagulation Analyzer, Toa Medical Electronics USA, Inc. (1993) Summary page 2.
- K933886: Toa Medical Electronics CA-5000, Toa Medical Electronics USA, Inc. (1994) Summary page 2.
- K942096: Toa Medical Electronics CA-1000, Sysmex Corp. (1995) Summary page 2.
- K942097: Toa Medical Electronics CA-5000, Sysmex Corp. (1995) Summary page 2.

## Indications for use
Sysmex® CA-1000 & CA-5000 are intended for use as automated blood plasma coagulation analyzers.

Source page: https://510kreport.com/device/K964946
Methodology: https://510kreport.com/methodology