Cardiovascular · 510(k) · 2025
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
Empatica S.R.L.. Cleared by FDA on 6 June 2025 under submission K242737, product code MWI (monitor, physiological, patient (without arrhythmia detection or alarms)). What FDA's record says, in FDA's words.
Device record · K242737
- Device. Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalDEVICE
- Company. Empatica S.R.L. (IT)COMPANY
- Decision. 6 June 2025, 510(k), substantially equivalent (traditional review); received 11 September 2024DECISION
- Panel. CardiovascularPANEL
- Product code. MWI, Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)CODE
- Regulation. 21 CFR 870.2300, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 2,174 reports filed against devices carrying product code MWI. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · Rad-97 · Masimo - 15750 Alton Pkwy · report 3019388613-2026-00708
The customer reported that the device has an audio speaker failure and tb-20 intermittent connection issues. There was no patient impact or consequence reported.
29 September 2026 · Malfunction · Rad-97 · Masimo - 15750 Alton Pkwy · report 3019388613-2026-00705
The customer reported that "after power on the device turn off by itself with no alarm or error message". There was no patient impact or consequence reported.
29 September 2026 · Malfunction · Root · Masimo - 15750 Alton Pkwy · report 3019388613-2026-00707
The customer reported that sometimes it has turned off by itself with no message or alarm. There was no patient impact or consequence reported.
28 September 2026 · Malfunction · Rad-97 with NIBP · Masimo - 15750 Alton Pkwy · report 3019388613-2026-00700
The customer reported that the device will not power on most of the time. if it does turn on, it shuts off by itself. There was no patient impact or consequence reported.
28 September 2026 · Injury · Expression MR400 MRI Patient Monitoring System (Model MR400) · Philips North America LLC · report 50914635
Patient underwent MRI scan with use of Phillips Expression MR400 MRI Patient Monitoring System. After the MRI, he was noted to have a left chest wall burn. Plastic Surgery noted a full thickness chest wall burn that later required surgical debridement and split thickness skin grafting. Manufacturer response for MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS), Expression MR400 MRI Patient Monitoring System (Model MR400) (per site reporter).Provided with IFU changes from […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MWI, in Cardiovascular, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.