Product code DXNClass 2
System, Measurement, Blood-Pressure, Non-Invasive 510(k) Clearances
Product code DXN is the FDA classification for System, Measurement, Blood-Pressure, Non-Invasive, a Class 2 device regulated under 21 CFR 870.1130, reviewed by the FDA Cardiovascular panel. FDA has cleared 1,214 510(k) submissions under this product code.
Every device cleared under product code DXN shares the same intended use and device type, so they are candidate predicate devices for a new 510(k) of this type. Open any device below to see its full clearance record and its candidate predicates.
- Cleared devices
- 1,214
- Device class
- Class 2
- Regulation
- 870.1130
- Latest clearance
- 2026-06-03
Cleared devices under product code DXN
Showing the 50 most recent of 1,214 cleared devices. Clearances from 2024-10-04 to 2026-06-03.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253124 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-03 |
| K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | 2026-05-20 |
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | Shenzhen Urion Technology Co., Ltd. | 2026-05-14 |
| K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | 2026-05-06 |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | Honsun (Nantong) Co., Ltd. | 2026-04-28 |
| K252501 | 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) | Joytech Healthcare Co. , Ltd. | 2026-04-28 |
| K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | 2026-04-21 |
| K260276 | 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 | Shenzhen AOJ Medical Technology Co., Ltd. | 2026-04-01 |
| K254225 | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Shenzhen HanHan Technology Co., Ltd. | 2026-04-01 |
| K260273 | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | Shenzhen Urion Technology Co., Ltd. | 2026-03-26 |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-03-05 |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-23 |
| K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-02-13 |
| K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-02-13 |
| K252685 | 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) | Joytech Healthcare Co. , Ltd. | 2026-02-13 |
| K251307 | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-01-12 |
| K253142 | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) | Ningbo Ranor Medical Technology Co., Ltd. | 2026-01-09 |
| K251143 | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2025-12-19 |
| K251331 | Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. | 2025-10-27 |
| K251795 | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | Honsun (Nantong) Co., Ltd. | 2025-10-09 |
| K252769 | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) | Shenzhen Finicare Co., Ltd. | 2025-10-02 |
| K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) | Dongguan E-Test Technology Co., Ltd. | 2025-09-03 |
| K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) | Microlife Corporation | 2025-08-06 |
| K251113 | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr | Andon Health Co, Ltd. | 2025-08-04 |
| K244007 | ArteVu | Cardio Ring Technologies, Inc. Taiwan Branch | 2025-07-30 |
| K251102 | Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) | Cemho Medical Technology (Guangdong) Co., Ltd. | 2025-07-16 |
| K250185 | Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) | Jiangxi Aicare Medical Technology Co., Ltd. | 2025-07-14 |
| K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | 2025-07-02 |
| K250548 | Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | Joytech Healthcare Co. , Ltd. | 2025-06-26 |
| K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-05-02 |
| K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-04-30 |
| K250116 | Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-04-24 |
| K250136 | Globalcare Blood Pressure Monitor (GUS610) | Globalcare Medical Technology Co., Ltd. | 2025-04-08 |
| K250091 | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Korot Co., Ltd. | 2025-03-14 |
| K243115 | Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | Shenzhen Urion Technology Co., Ltd. | 2025-02-21 |
| K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | Shenzhen Bsx Technology Electronics Co., Ltd. | 2025-02-19 |
| K241634 | Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-11 |
| K243661 | Electronic Blood Pressure Monitor | Hetaida Technology Co., Ltd. | 2025-02-07 |
| K242352 | Accurate Mini Non-invasive blood pressure monitor (AMB-001) | Accurate Meditech, Inc. | 2025-02-05 |
| K241590 | Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-03 |
| K242568 | Wrist Blood Pressure Monitor (OHMS11, OHMS12) | Shenzhen Zhongkemingwang Telecommunications Software Corp. | 2025-01-30 |
| K241728 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 | Murata Vios, Inc. | 2025-01-23 |
| K241066 | BB-613-BPM | Biobeat Technologies , Ltd. | 2025-01-14 |
| K241431 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) | Joytech Healthcare Co. , Ltd. | 2025-01-13 |
| K242528 | Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) | Shenzhen Ruiankang Technology Co., Ltd. | 2025-01-10 |
| K243118 | Arm Blood Pressure Monitor (model: BPM-A7VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2024-11-26 |
| K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | Shenzhen Urion Technology Co., Ltd. | 2024-10-24 |
| K242193 | Arm Type Blood Pressure Monitor (BPM82) | Avita Corporation | 2024-10-22 |
| K241613 | Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) | Shenzhen Hbcare Technology Co.,Ltd | 2024-10-16 |
| K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) | Shenzhen Finicare Co., Ltd. | 2024-10-04 |
Filing a 510(k) for a System, Measurement, Blood-Pressure, Non-Invasive of this type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.