FDA product code · Cardiovascular
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Product code DRT covers Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II device regulated under 21 CFR 870.2300. FDA has cleared 339 devices in this code, 3 of them in the last 12 months. Median review time across the 339 most recent decisions is 90 days. openFDA lists 11 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.2300
- Review panel
- Cardiovascular
- Clearances
- 339
What is happening in DRT right now?
DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)) has two findings, most consequential first. 1 first-time filer in the last 12 months, Circadia Health, Inc (K252676). The code is crowded, scoring 75 of 100 — 161 companies hold a clearance here and 3 arrived in the last 12 months (DRT:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K252676 |
| Crowding | Context | DRT: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 DRT?
FDA has cleared 339 devices under product code DRT since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261286 | The Circadia C300 System (C300) | Circadia Health, Inc. | |
| K252676 | The Circadia C300 System (C300) | Circadia Health, Inc. | |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | |
| K251364 | Sleepiz One+ (2.5) | Sleepiz AG | |
| K234003 | The Circadia C200 System | Circadia Technologies, Ltd. | |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | Murata Vios, Inc. | |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | |
| K223163 | Sleepiz One+ | Sleepiz AG | |
| K212143 | Neteera 130H/131H Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | |
| K202138 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. |
How long does FDA review take for DRT?
The median FDA review time for DRT is 90 days, measured across the 339 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 DRT?
openFDA lists 11 recall records against product code DRT. A recall record covers one firm's corrective action and may span many device lots.
Z-1292-2025Open, ClassifiedMurata Vios, Inc.
Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
Z-1069-2025Open, ClassifiedMurata Vios, Inc.
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.
Z-1169-2025Open, ClassifiedMurata Vios, Inc.
A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
Z-0956-2025CompletedMurata Vios, Inc.
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.
Z-2268-2014TerminatedAnsar Group, Inc. Dba Ansar Medical Technologies, Inc
The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured.
Showing the 5 most recently initiated of 11. 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 DRT?
MAUDE holds 127 adverse-event reports naming product code DRT, 49 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 DRT unusual?
DRT 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 | |
| 5 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history |
30 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 DRT in the last year?
One company filed in DRT for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Circadia Health, Inc. | K252676 |
"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 DRT?
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 DRT?
Across the 339 most recent decisions, these applicants filed most often in DRT.
| Applicant | Recent clearances |
|---|---|
| Hewlett-Packard Co. | 20 |
| Litton Medical Electronics | 17 |
| Ivy Biomedical Systems, Inc. | 10 |
| Life Science Instrumentation, Inc. | 10 |
| Nihon Kohden America, Inc. | 10 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch DRT
Get an email the morning anything changes in DRT — 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.