FDA product code · Cardiovascular
DXHTransmitters And Receivers, Electrocardiograph, Telephone
Product code DXH covers Transmitters And Receivers, Electrocardiograph, Telephone, a Class II device regulated under 21 CFR 870.2920. FDA has cleared 297 devices in this code, 4 of them in the last 12 months. Median review time across the 297 most recent decisions is 107 days. openFDA lists 10 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.2920
- Review panel
- Cardiovascular
- Clearances
- 297
What is happening in DXH right now?
DXH (Transmitters And Receivers, Electrocardiograph, Telephone) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2306-2026). 4 first-time filers in the last 12 months, including Measure Labs, Inc. (Dba Preemptiveai, Inc.) and Heartbeam, Inc (K250233, K250258, K243438, K243981). The code is crowded, scoring 84 of 100 — 141 companies hold a clearance here and 4 arrived in the last 12 months (DXH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2306-2026 |
| New entrant | Worth knowing | K250233, K250258, K243438, K243981 |
| Crowding | Context | DXH: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 DXH?
FDA has cleared 297 devices under product code DXH since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | |
| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. | |
| K243438 | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | |
| K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | |
| K243003 | VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. | |
| K233521 | QT ECG (QTERD100) | QT Medical, Inc. | |
| K222842 | V-Patch Cardiac Monitor | Shandong Corecare Technology Limited | |
| K220795 | QT ECG | QT Medical, Inc. | |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | |
| K220350 | KardiaMobile 6L | AliveCor, Inc. |
How long does FDA review take for DXH?
The median FDA review time for DXH is 107 days, measured across the 297 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 DXH?
openFDA lists 10 recall records against product code DXH. A recall record covers one firm's corrective action and may span many device lots.
Z-2306-2026Open, ClassifiedGE Medical Systems China Co., Ltd.
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.
Z-0172-2016TerminatedSpacelabs Healthcare, Inc.
When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally.
Z-1125-2015TerminatedAlivecor SFO
Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
Z-0206-2012TerminatedLifewatch Services, Inc.
LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
Z-0207-2012TerminatedLifewatch Services, Inc.
LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
Showing the 5 most recently initiated of 10. 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 DXH?
MAUDE holds 33 adverse-event reports naming product code DXH, 27 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 DXH unusual?
DXH does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
11 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.
Who has entered DXH in the last year?
4 companies filed in DXH for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Measure Labs, Inc. (Dba Preemptiveai, Inc.) | K250233 | |
| Heartbeam, Inc. | K250258 | |
| Huinno Co., Ltd. | K243438 | |
| Carre Technologies, Inc. | K243981 |
"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 DXH?
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 DXH?
Across the 297 most recent decisions, these applicants filed most often in DXH.
| Applicant | Recent clearances |
|---|---|
| Card Guard Scientific Survival , Ltd. | 28 |
| Instromedix, Inc. | 16 |
| Medtronic Vascular | 15 |
| AliveCor, Inc. | 10 |
| Universal Medical, Inc. | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in DXH files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Instromedix, Inc. | 17 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch DXH
Get an email the morning anything changes in DXH — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Cardiovascular
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.