Cardiovascular · 510(k) · 2020
Eko Analysis Software
Eko Devices Inc. Cleared by FDA on 15 January 2020 under submission K192004, product code MWI (monitor, physiological, patient (without arrhythmia detection or alarms)). What FDA's record says, in FDA's words.
Device record · K192004
- Device. Eko Analysis SoftwareDEVICE
- Company. Eko Devices IncCOMPANY
- Decision. 15 January 2020, 510(k), substantially equivalent (traditional review); received 26 July 2019DECISION
- 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 (8 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 Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias. It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years).
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.
- Modalities namedECG
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- 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, from Eko Devices Inc, or cleared in 2020. 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.