DeviceClearance

Product code JPA— Hematology

Sysmex Automated Blood Coagulation Analyzer CS-5100

Classification name
System, Multipurpose For In Vitro Coagulation Studies
Device class
Class 2
Regulation
21 CFR 864.5425
Advisory panel
Hematology
Total cleared
181
First cleared
Most recent

Market context for product code JPA

FDA has cleared 181 devices under product code JPA between 1976 and 2026, filed by 68 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code JPA

Adverse events under product code JPA

product code JPA
Death
6
Total
6

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code JPA

1–100 of 181

Data sourced from openFDA. This site is unofficial and independent of the FDA.