Cardiovascular · 510(k) · 2025
Eko Foundation Analysis Software with Transformers (EFAST)
Eko Health, Inc.. Cleared by FDA on 12 August 2025 under submission K251494, product code DQD (stethoscope, electronic). What FDA's record says, in FDA's words.
Device record · K251494
- Device. Eko Foundation Analysis Software with Transformers (EFAST)DEVICE
- Company. Eko Health, Inc.COMPANY
- Decision. 12 August 2025, 510(k), substantially equivalent (traditional review); received 15 May 2025DECISION
- Panel. CardiovascularPANEL
- Product code. DQD, Stethoscope, ElectronicCODE
- Regulation. 21 CFR 870.1875, Class IIREG
- Source. FDA database entry · decision document (14 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 Foundation Analysis Software with Transformers (EFAST) is intended to support healthcare professionals in the evaluation of patients’ heart sounds and electrocardiograms (ECGs). The software calculates heart rate, detects the presence of murmurs associated with Structural Heart Disease, and determines murmur timing, including the timing of S1, S2 heart sounds. When ECG is available, the software detects the presence of atrial fibrillation and normal sinus rhythm. The software is intended for use by or under the supervision of a healthcare professional and is not to be used as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are designed to support and not replace the healthcare professional’s clinical judgment. The murmur detection is intended for use on both pediatric and adult patients, while the detection of atrial fibrillation is intended for use on adults (> 18 years). of 10 SUBSTANTIAL EQUIV ALENCE The Eko Foundation Analysis Software with Transformers (EFAST) has the same intended use and fundamental technological characteristics as both the predicate (Eko Murmur Analysis Software, EMAS). Differences in ECG analysis, patient population, and technological characteristics do not raise new questions on safety or effectiveness compared to the predicate and reference devices. A substantial equivalence comparison table between the subject device and the predicate device is provided below. Table 1: […]
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
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 7 reports filed against devices carrying product code DQD. 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:
31 August 2026 · Malfunction · CORE 500 Digital Stethoscope · Eko Health, Inc. · report 3011651230-2026-00002
31 August 2026 · Malfunction · CORE 500 Digital Stethoscope · Eko Health, Inc. · report 3011651230-2026-00003
8 May 2026 · Malfunction · EKO ELECTRONIC STETHOSCIPE SYSTEM · EKO HEALTH, INC. · report 3011651230-2026-00001
CUSTOMER REPORTED WHILE CHARGING THEIR DEVICE THE DEVICE BECAME VERY HOT. THE DEVICE BECAME HOT TO THE POINT THE USER COULD NOT TOUCH THE DEVICE. FOLLOWING THE EVENT THE DEVICE WAS NO LONGER ABLE TO POWER ON. NO DEATH OR SERIOUS INJURY REPORTED.
12 November 2024 · Malfunction · CORE 500 DIGITAL STETHOSCOPE · EKO HEALTH, INC. · report 3011651230-2024-00001
CUSTOMER REPORTED THAT THE REFERENCED DEVICE OVERHEATED AND THE USB-C CHARGING CABLE MELTED DURING CHARGING. NO DEATH OR SERIOUS INJURY REPORTED.
12 November 2013 · Other · 3M LITTMANN ELECTRONIC STETHOSCOPE · 3M HEALTH CARE · report 2110898-2013-00071
IT WAS REPORTED THAT A FEMALE RESPIRATORY THERAPIST, WITH A SEVERE LATEX ALLERGY, REPORTED SHE USED A SOFT BLACK EAR TIP THAT SHE BORROWED FROM HER BOSS AFTER HER SOFT GREY EAR TIP SPLIT. REPORTEDLY, SHE CLEANED IT WITH ALCOHOL BEFORE USING IT ON HER SCOPE. THE USER USED IT IN A PATIENT'S ROOM AND HER EAR BECAME BEET RED, SWOLLEN, STARTED ITCHING AND THE REACTION SPREAD TO HER HEAD, FACE, AND ARM. REPORTEDLY WENT TO THE ER AND WAS TREATED WITH BENADRYL AND DECADRON (IM INJECTION) AND A […]
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 DQD, in Cardiovascular, from Eko Health, Inc., 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.