FDA product code · Cardiovascular
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Product code DRG covers Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II device regulated under 21 CFR 870.2910. FDA has cleared 192 devices in this code, 3 of them in the last 12 months. Median review time across the 192 most recent decisions is 99 days. openFDA lists 11 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.2910
- Review panel
- Cardiovascular
- Clearances
- 192
What is happening in DRG right now?
DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency) has two findings, most consequential first. 2 first-time filers in the last 12 months, Perin Health Devices, LLC and Ingeniars S.R.L (K252984, K252440). The code is crowded, scoring 76 of 100 — 124 companies hold a clearance here and 3 arrived in the last 12 months (DRG:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K252984, K252440 |
| Crowding | Context | DRG: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 DRG?
FDA has cleared 192 devices under product code DRG 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 |
|---|---|---|---|
| K261569 | UbiqVue 2AYe Cardiac System (UX2253) | Lifesignals, Inc. | |
| K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | |
| K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | |
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | |
| K243837 | iBSM | Iorbit Digital Technologies Private Limited | |
| K242018 | UbiqVue 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | |
| K241101 | BioButton System | Biointellisense, Inc. | |
| K240251 | ANNE Chest | Sibel Health, Inc. | |
| K223711 | ANNE One | Sibel Health, Inc. | |
| K220526 | HD+12, HD+15 | Cardioline S.P.A |
How long does FDA review take for DRG?
The median FDA review time for DRG is 99 days, measured across the 192 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 DRG?
openFDA lists 11 recall records against product code DRG. A recall record covers one firm's corrective action and may span many device lots.
Z-2616-2024Open, ClassifiedBiointellisense Inc.
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Z-1162-2021Open, ClassifiedNihon Kohden America Inc
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Z-2537-2020TerminatedVitalconnect Inc.
A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was found. A software defect was encountered causing the lack of notification. The defect could result in exposing a patient to potential hypoxia for a short window of time. The firm is correcting the software to bring the performance back into compliance with specifications.
Z-3132-2017TerminatedBoston Scientific Corporation
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Z-1708-2017TerminatedPhilips Visicu
eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.
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 DRG?
MAUDE holds 113 adverse-event reports naming product code DRG, 55 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 DRG unusual?
Every month with enough history behind it falls inside DRG's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 3 | 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 | |
| 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 | |
| 6 | 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 | |
| 2 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 5 | 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 | |
| 2 | 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 | |
| 6 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 8 | 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 | |
| 6 | 0–12 | Within expected (0–12) | |
| 9 | 0–13 | Within expected (0–13) |
29 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 DRG.
Who has entered DRG in the last year?
2 companies filed in DRG for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Perin Health Devices, LLC | K252984 | |
| Ingeniars S.R.L. | K252440 |
"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 DRG?
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 DRG?
Across the 192 most recent decisions, these applicants filed most often in DRG.
| Applicant | Recent clearances |
|---|---|
| Vitalconnect, Inc. | 9 |
| American Telecare, Inc. | 5 |
| General Devices | 5 |
| Honeywell Hommed, LLC | 5 |
| Nihon Kohden America, Inc. | 5 |
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 DRG 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 |
|---|---|---|
| Honeywell Hommed, LLC | 6 | 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 DRG
Get an email the morning anything changes in DRG — 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.