JKAClass II

Tubes, Vials, Systems, Serum Separators, Blood Collection

21 CFR 862.1675 / Clinical Chemistry

JKA is the FDA product code for Tubes, Vials, Systems, Serum Separators, Blood Collection, a class II device type, regulated under 21 CFR 862.1675. As of 2026-09-10, FDA records hold 236 510(k) clearances under this code, the most recent dated 2026-06-02, and 170 recalls.

Classification record

Product code: JKA
Device name: Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation: 21 CFR 862.1675
Device class: Class II
Review panel: Clinical Chemistry
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 237
Ingested recalls: 170

Clearances, product code JKA

By decision year

237 clearances under product code JKA with a decision year between 1977 and 2026, 2023 the highest year at 16.

Show the numbers

510(k) clearances under FDA product code JKA by decision year
Year	Clearances
1977	1
1978	1
1979	2
1980	4
1981	4
1982	3
1983	7
1984	1
1985	2
1986	2
1987	2
1988	8
1989	6
1990	7
1991	6
1992	6
1993	8
1994	10
1995	13
1996	7
1997	6
1998	13
1999	6
2000	4
2001	1
2002	9
2003	6
2004	3
2005	2
2006	2
2007	4
2008	2
2009	2
2010	4
2012	1
2013	3
2014	1
2015	1
2016	4
2017	2
2018	1
2019	6
2020	6
2021	4
2022	9
2023	16
2024	6
2025	7
2026	6

Applicants with the most clearances

Product code JKA

Applicants holding the most 510(k) clearances under product code JKA
Applicant	Clearances
Becton Dickinson & Co	26
BD Becton Dickinson Vacutainer Systems Preanalytic	13
Becton Dickinson Vacutainer Systems	11
Sherwood Medical Co.	9
Becton Dickinson Infusion Therapy Systems Inc.	8
Greiner America, Inc.	6
Greiner Bio-One North America, Inc.	6
Greiner Meditech, Inc.	6
Starplex Scientific Corp.	5
Sudormed, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 200 companies shown, in name order