FDA 510(k) ClearanceDXN
Accurate Mini Non-invasive blood pressure monitor (AMB-001)
FDA 510(k) K242352 · Accurate Meditech, Inc.
- 510(k) number
- K242352
- Device name
- Accurate Mini Non-invasive blood pressure monitor (AMB-001)
- Applicant
- Accurate Meditech, Inc.
- Product code
- DXN
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 870.1130
- Advisory committee
- CV
- Medical specialty
- Cardiovascular
Candidate predicate devices
Other devices cleared under product code DXN form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation | |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | |
| K253126 | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. | |
| K260693 | VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH | |
| K253059 | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | |
| K253124 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | |
| K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | |
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | Shenzhen Urion Technology Co., Ltd. | |
| K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | |
| 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. | |
| 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. | |
| K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. |
Building a 510(k) around this device 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.