DXNClass II

System, Measurement, Blood-Pressure, Non-Invasive

21 CFR 870.1130 / Cardiovascular

DXN is the FDA product code for System, Measurement, Blood-Pressure, Non-Invasive, a class II device type, regulated under 21 CFR 870.1130. As of 2026-09-10, FDA records hold 1,222 510(k) clearances under this code, the most recent dated 2026-08-26, and 36 recalls.

Classification record

Product code: DXN
Device name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation: 21 CFR 870.1130
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 1,225
Ingested recalls: 36

Clearances, product code DXN

By decision year

1,225 clearances under product code DXN with a decision year between 1976 and 2026, 2009 the highest year at 46.

Show the numbers

510(k) clearances under FDA product code DXN by decision year
Year	Clearances
1976	2
1977	14
1978	11
1979	12
1980	23
1981	8
1982	20
1983	19
1984	25
1985	40
1986	27
1987	21
1988	18
1989	14
1990	11
1991	19
1992	13
1993	9
1994	15
1995	13
1996	8
1997	4
1998	12
1999	24
2000	32
2001	29
2002	30
2003	32
2004	44
2005	43
2006	33
2007	27
2008	23
2009	46
2010	43
2011	34
2012	36
2013	34
2014	29
2015	30
2016	30
2017	33
2018	22
2019	33
2020	24
2021	23
2022	25
2023	35
2024	17
2025	28
2026	28

Applicants with the most clearances

Product code DXN

Applicants holding the most 510(k) clearances under product code DXN
Applicant	Clearances
Andon Health Co., Ltd	68
Health & Life Corporation	55
Omron Healthcare Co., Ltd.	36
Microlife Intellectual Property GmbH	33
A and D Engineering, Inc.	25
Grandway Technology (Shenzhen) Limited	21
Nihon Seimitsu Sokki Co., Ltd.	18
Guangdong Transtek Medical Electronics Co.,Ltd	14
Rossmax International Ltd.	14
Joytech Healthcare Co., Ltd.	13

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 406 companies shown, in name order