DeviceClearance

Product code JKA— Clinical Chemistry

GREINER VACUETTE BLOOD COLLECTION TUBE

Classification name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class
Class 2
Regulation
21 CFR 862.1675
Advisory panel
Clinical Chemistry
Total cleared
237
First cleared
Most recent

Market context for product code JKA

FDA has cleared 237 devices under product code JKA between 1977 and 2026, filed by 116 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 JKA

Adverse events under product code JKA

product code JKA
Injury
455
Malfunction
26,686
Other
4
Total
27,145

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 JKA

1–100 of 237

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