510(k) · Cleared

Cleared

CORE 500 Digital Stethoscope

K230111510(k) TraditionalCleared May 26, 2023129-day reviewClass II21 CFR 870.1875

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eko Devices, Inc. · DQD Stethoscope, Electronic

Cleared on May 26, 2023 as substantially equivalent to K170874 (Eko Devices, Inc., 2017) after a 129-day review. Its family tree reaches back 1 generation to 2017. 1 later device descends from it.

Decided: May 26, 2023
Review: 129 days
Class: Class II
Product code: DQD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K170874 (2017). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK170874 Eko Model E5 System (EME5), Eko DUOEko Devices, Inc. · 2017
This deviceK230111 CORE 500 Digital StethoscopeEko Devices, Inc. · 2023
Descendant · cites it directly · 0 of its ownK233609 CORE 500 Digital StethoscopeEko Health, Inc. · 2024

Most influential descendants

Showing 1 of 1 · See all

K233609CORE 500 Digital StethoscopeEko Health, Inc. · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K170874	Eko Model E5 System (EME5), Eko DUO	Eko Devices, Inc.	2017	—
0 (this device)	K230111	CORE 500 Digital Stethoscope	Eko Devices, Inc.	2023	—
+1	K233609	CORE 500 Digital Stethoscope	Eko Health, Inc.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0

FIG. 1 — Lineage of K230111, 2017–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQD device

#1 K200776 Eko COREscore 25.2 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K170874	Eko Model E5 System (EME5), Eko DUO Summary page 4 …Classification Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD, DPS PREDICATE DEVICE Predicate Device: Eko Model E5 System (EME5), Eko DUO (K170874) Reference Device: Eko Analysis Software (EAS) (K192004) DEVICE DESCRIPTION CORE 500 Digital Stethoscope (CORE 500) is an elect…	Eko Devices, Inc.	2017	—
†	K192004	Eko Analysis Software	Eko Devices, Inc.	2020	—

Also cleared against K170874: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K233609	CORE 500 Digital Stethoscope	Eko Health, Inc.	2024	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K233609 (Eko Health, Inc., 2024) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K170874.

How does its category compare?

All DQD devices

DQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · DQD

3in 2025

2007high 10 (2023) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQD

89in 2025

2007high 262 (2019) · low 70 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQD

No recall names DQD since 2007.

Adverse event reports per year · DQD

1in 2024

2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code DQD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	0
2008	1	—	0
2009	6	161	0
2010	1	—	0
2011	4	107	1
2012	2	—	0
2013	5	70	1
2014	0	—	0
2015	2	—	0
2016	3	250	0
2017	4	109	0
2018	4	131	0
2019	4	262	0
2020	6	104	0
2021	4	137	0
2022	8	203	0
2023	10	132	0
2024	4	153	1
2025	3	89	0
2026	6	236	—

What is it indicated for?

The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).

The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K230111 · printed Nov 6, 2026

Cite this page

510(k) Report. “K230111: CORE 500 Digital Stethoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230111

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026