510(k) · Cleared

Cleared

CORE 500 Digital Stethoscope

K233609510(k) TraditionalCleared Mar 28, 2024136-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 Health, Inc. · DQD Stethoscope, Electronic

Cleared on Mar 28, 2024 as substantially equivalent to K230111 (Eko Devices, Inc., 2023) after a 136-day review. Its family tree reaches back 2 generations to 2017.

Decided: Mar 28, 2024
Review: 136 days
Class: Class II
Product code: DQD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K170874 (2017). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK170874 Eko Model E5 System (EME5), Eko DUOEko Devices, Inc. · 2017
1 generation backK230111 CORE 500 Digital StethoscopeEko Devices, Inc. · 2023
This deviceK233609 CORE 500 Digital StethoscopeEko Health, Inc. · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K170874	Eko Model E5 System (EME5), Eko DUO	Eko Devices, Inc.	2017	—
−1	K230111	CORE 500 Digital Stethoscope	Eko Devices, Inc.	2023	—
0 (this device)	K233609	CORE 500 Digital Stethoscope	Eko Health, Inc.	2024	—

FIG. 1 — Lineage of K233609, 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

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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
*	K230111	CORE 500 Digital Stethoscope Summary page 5 …Device Classification Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD, DPS PREDICATE DEVICE Primary Predicate: CORE 500 Digital Stethoscope (K230111) Reference Device: Eko CORE (K200776) DEVICE DESCRIPTION CORE 500 Digital Stethoscope (CORE 500) is an electronic stethoscope w…	Eko Devices, Inc.	2023	—
†	K200776	Eko CORE	Eko Devices, Inc.	2020	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All DQD devices

DQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 or lay users 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 or by lay users).

A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

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/K233609 · printed Nov 6, 2026

Cite this page

510(k) Report. “K233609: 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/K233609

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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