FDA product code DXN: System, Measurement, Blood-Pressure, Non-Invasive
DXN is the FDA product code for system, measurement, blood-pressure, non-invasive. It is a Class II device, regulated under 21 CFR 870.1130 and reviewed by the Cardiovascular panel. FDA has cleared 1,225 510(k) submissions under DXN, 133 in the last five years, from 461 different applicants. The average 510(k) review took 137 days (median 110); 152 days on average over the last three years. FDA has posted 36 recalls for DXN devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class II |
| Regulation | 21 CFR 870.1130 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 33 | 198 |
| 2018 | 22 | 227 |
| 2019 | 33 | 201 |
| 2020 | 24 | 193 |
| 2021 | 23 | 205 |
| 2022 | 25 | 191 |
| 2023 | 35 | 187 |
| 2024 | 17 | 133 |
| 2025 | 28 | 158 |
| 2026 | 28 | 164 |
Compare with all 510(k) review times · Search every DXN clearance
Top DXN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Andon Health Co, Ltd. | 68 | 2025-08-04 |
| Health & Life Co., Ltd. | 55 | 2021-09-08 |
| Omron Healthcare, Inc. | 36 | 2021-04-01 |
| Microlife Intellectual Property GmbH | 33 | 2023-06-28 |
| A&D Engineering, Inc. | 25 | 2008-11-13 |
456 more applicants have DXN clearances. See the full list in Caduvo.
Most recent DXN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261929 | OMRON Healthcare, Inc. | Upper Arm Blood pressure monitor (BP7155D) | 2026-09-10 | 93 |
| K254000 | Happy Health, Inc. | Happy Health Blood Pressure Monitor | 2026-09-03 | 262 |
| K262658 | Honsun (Nantong) Co., Ltd. | Automatic Digital Blood Pressure monitor (LD-526) | 2026-08-31 | 32 |
| K261394 | JOYTECH Healthcare Co., Ltd. | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) | 2026-08-26 | 119 |
| K261061 | Wellvii, Inc. | BP Go (BPP-855) | 2026-08-13 | 135 |
Recalls for DXN devices
36 product recalls in 23 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2025-02-24.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 3 |
| 2024 | 7 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code DXN?
DXN is the FDA product code for system, measurement, blood-pressure, non-invasive. It is a Class II device, regulated under 21 CFR 870.1130 and reviewed by the Cardiovascular panel.
What device class is DXN?
Class II, regulation 21 CFR 870.1130. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXN?
Across 1,225 cleared submissions the average was 137 days from receipt to decision (median 110).
Which companies have the most DXN clearances?
Andon Health Co, Ltd. (68); Health & Life Co., Ltd. (55); Omron Healthcare, Inc. (36); Microlife Intellectual Property GmbH (33); A&D Engineering, Inc. (25).
Have DXN devices been recalled?
Yes: 36 product recalls across 23 recall events; the most recent began 2025-02-24.
Next steps
- Run an FDA pathway report with predicate devices for product code DXN
- Run a recall and safety report across every DXN manufacturer
- Watch product code DXN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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