Chrysalis Intelligence · Product Codes · DXN

DXN · System, Measurement, Blood-Pressure, Non-Invasive

Cardiovascular · 176 clearances · 89 unique sponsors

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Device class
Class II
Regulation 870.1130
Total clearances
176
2020-01-23 → 2026-08-13
Last 12 months
29
Unique sponsors
89
Classification details
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.1130
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Guangdong Transtek Medical Electronics Co., Ltd. 11 0 2024-08-21
Joytech Healthcare Co. , Ltd. 10 3 2026-08-13
Shenzhen AOJ Medical Technology Co., Ltd. 7 1 2026-04-01
Microlife Intellectual Property GmbH 7 0 2023-06-28
Shenzhen Jamr Technology Co., Ltd. 6 2 2026-05-20
Andon Health Co, Ltd. 5 0 2025-08-04
Alicn Medical Shenzhen, Inc. 5 0 2023-10-11
Shenzhen Urion Technology Co., Ltd. 4 2 2026-05-14
Dongguan E-Test Technology Co., Ltd. 4 1 2025-09-03
Inbody Co., Ltd. 4 0 2023-08-02
Shenzhen Finicare Co., Ltd. 4 1 2025-10-02
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. 4 2 2026-03-05
Shenzhen Hingmed Medical Instrument Co., Ltd. 3 2 2026-02-13
Edwards Lifesciences, LLC 3 0 2023-10-24
Shenzhen Yuezhongxing Technology Co., Ltd. 3 0 2024-03-15
Globalcare Medical Technology Co., Ltd. 3 0 2025-04-08
Shenzhen Yolanda Technology Co., Ltd. 2 0 2023-06-29
Accurate Meditech, Inc. 2 0 2025-02-05
Hetaida Technology Co., Ltd. 2 0 2025-02-07
Zhuhai Yueja Medical Device Technology Co., Ltd. 2 0 2023-12-11
Jiangxi Aicare Medical Technology Co., Ltd. 2 0 2025-07-14
Ningbo Ranor Medical Science & Technology Co., Ltd. 2 1 2025-12-19
Guangdong Xinyu Electronic and Technology Co., Ltd. 2 0 2025-02-11
Avita Corporation 2 0 2024-10-22
Shenzhen Imdk Medical Technology Co., Ltd. 2 1 2026-02-13
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
94060 CPT — Medium Comprehensive systemic pressure measurements during rest, exercise, and/or sustained inflation
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-13 K261061 Wellvii, Inc. BP Go (BPP-855)
2026-08-13 K253425 Joytech Healthcare Co. , Ltd. Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)
2026-07-23 K261136 Guangzhou Daxin Health Technology Co., Ltd. Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
2026-07-23 K261082 Microlife Corporation Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)
2026-06-18 K253126 Shenzhen Ziqing Medical Equipment Co., Ltd. Wrist Blood Pressure Monitor (XW-05)
2026-06-16 K260693 80 Beats Medical GmbH VicorderCS (VCS-SYS-1100)
2026-06-15 K253059 Tournicare Pty, Ltd. Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
2026-06-03 K253124 Shenzhen Ziqing Medical Equipment Co., Ltd. Upper arm electronic blood pressure monitor (XB-01)
2026-05-20 K253570 Shenzhen Jamr Technology Co., Ltd. Blood Pressure Monitor (W06LT)
2026-05-14 K254048 Shenzhen Urion Technology Co., Ltd. Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
2026-05-06 K253152 Biozen, LLC BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
2026-04-28 K260260 Honsun (Nantong) Co., Ltd. Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)
2026-04-28 K252501 Joytech Healthcare Co. , Ltd. Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)
2026-04-21 K253982 Beijing Hanvon Health Technology Co., Ltd. Korotkoff sound blood pressure monitor
2026-04-01 K260276 Shenzhen AOJ Medical Technology Co., Ltd. Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro
2026-04-01 K254225 Shenzhen HanHan Technology Co., Ltd. Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
2026-03-26 K260273 Shenzhen Urion Technology Co., Ltd. Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
2026-03-05 K252779 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. YUWELL® Electronic Blood Pressure Monitor (YE630CR)
2026-02-23 K253228 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. YUWELL® Electronic Blood Pressure Monitor (YE650AR)
2026-02-13 K253133 Shenzhen Imdk Medical Technology Co., Ltd. Wrist Blood Pressure Monitor (BPM-W1VL)
2026-02-13 K252685 Joytech Healthcare Co. , Ltd. Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
2026-02-13 K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
2026-01-12 K251307 Shenzhen Hingmed Medical Instrument Co., Ltd. Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
2026-01-09 K253142 Ningbo Ranor Medical Technology Co., Ltd. Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
2025-12-19 K251143 Ningbo Ranor Medical Science & Technology Co., Ltd. Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence