FDA product code · Cardiovascular
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
Product code DXN covers System, Measurement, Blood-Pressure, Non-Invasive, a Class II device regulated under 21 CFR 870.1130. FDA has cleared 1,219 devices in this code, 27 of them in the last 12 months. Median review time across the 1,219 most recent decisions is 110 days. openFDA lists 36 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.1130
- Review panel
- Cardiovascular
- Clearances
- 1,219
What is happening in DXN right now?
DXN (System, Measurement, Blood-Pressure, Non-Invasive) has three findings, most consequential first. 8 first-time filers in the last 12 months, including Guangzhou Daxin Health Technology Co., Ltd. and 80 Beats Medical GmbH (K261136, K260693, K253059, K253124, K253152). Clearances are running 35% slower — a median 148 days over the last 12 months against 110 days all-time (elapsed calendar days, not FDA review days) (DXN:review_time:12m). The code is crowded, scoring 100 of 100 — 445 companies hold a clearance here and 27 arrived in the last 12 months (DXN:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K261136, K260693, K253059, K253124, K253152 |
| Review time | Context | DXN:review_time:12m |
| Crowding | Context | DXN:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in DXN?
FDA has cleared 1,219 devices under product code DXN since the 510(k) programme began in 1976, 27 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation | |
| 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 | |
| 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. |
How long does FDA review take for DXN?
The median FDA review time for DXN is 110 days, measured across the 1,219 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in DXN?
openFDA lists 36 recall records against product code DXN. A recall record covers one firm's corrective action and may span many device lots.
Z-1508-2025Open, ClassifiedPYRAMES INC
Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.
Z-0032-2025Open, ClassifiedMEDLINE INDUSTRIES, LP - Northfield
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
Z-0033-2025Open, ClassifiedMEDLINE INDUSTRIES, LP - Northfield
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
Z-0034-2025Open, ClassifiedMEDLINE INDUSTRIES, LP - Northfield
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
Z-1509-2024Open, ClassifiedBaxter Healthcare Corporation
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
Showing the 5 most recently initiated of 36. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for DXN?
MAUDE holds 705 adverse-event reports naming product code DXN, 150 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in DXN unusual?
Every month with enough history behind it falls inside DXN's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 12 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 103 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 9 | 0–69 | Within expected (0–69) | |
| 13 | 0–56 | Within expected (0–56) | |
| 22 | 0–62 | Within expected (0–62) | |
| 21 | 0–65 | Within expected (0–65) | |
| 59 | 0–61 | Within expected (0–61) | |
| 14 | 0–81 | Within expected (0–81) | |
| 19 | 0–118 | Within expected (0–118) | |
| 27 | 0–84 | Within expected (0–84) | |
| 7 | 0–88 | Within expected (0–88) | |
| 5 | 0–83 | Within expected (0–83) | |
| 25 | 0–48 | Within expected (0–48) | |
| 18 | 0–57 | Within expected (0–57) | |
| 26 | 0–65 | Within expected (0–65) | |
| 19 | 0–55 | Within expected (0–55) | |
| 25 | 0–60 | Within expected (0–60) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in DXN.
Who has entered DXN in the last year?
8 companies filed in DXN for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Guangzhou Daxin Health Technology Co., Ltd. | K261136 | |
| 80 Beats Medical GmbH | K260693 | |
| Tournicare Pty, Ltd. | K253059 | |
| Shenzhen Ziqing Medical Equipment Co., Ltd. | K253124 | |
| Biozen, LLC | K253152 | |
| Beijing Hanvon Health Technology Co., Ltd. | K253982 | |
| Shenzhen HanHan Technology Co., Ltd. | K254225 | |
| Ningbo Ranor Medical Technology Co., Ltd. | K253142 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in DXN?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in DXN?
Across the 1,219 most recent decisions, these applicants filed most often in DXN.
| Applicant | Recent 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 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch DXN
Get an email the morning anything changes in DXN — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.