510(k) · Cleared

Cleared

Cardiovascular Sonospectrographic Analyzer

K023759510(k) TraditionalCleared May 6, 2003179-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

Sonomedica · DQD Stethoscope, Electronic

Cleared on May 6, 2003 as substantially equivalent to K963418 (Transmedica, Inc., 1997) after a 179-day review. Its family tree reaches back 1 generation to 1997.

Decided: May 6, 2003
Review: 179 days
Class: Class II
Product code: DQD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K963418 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK963418 Transmedica Model 100 Digital Electronic StethoscopeTransmedica, Inc. · 1997
This deviceK023759 Cardiovascular Sonospectrographic AnalyzerSonomedica · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963418	Transmedica Model 100 Digital Electronic Stethoscope	Transmedica, Inc.	1997	—
0 (this device)	K023759	Cardiovascular Sonospectrographic Analyzer	Sonomedica	2003	—

FIG. 1 — Lineage of K023759, 1997–2003Source: 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
*	K963418	Transmedica Model 100 Digital Electronic Stethoscope Summary page 1 …3-734-0410 Contact: Sailor Mohler, Executive Vice President, Chief Technology Officer Phone: Fax: Predicate Device: Transmedica: Digital Electronic Stethoscope 510(k) 963418 Product Code DQD . CFR section: 3066%¢ ¢70. 1§75 Device Description The Cardiovascular Sonospectrographic Analyzer (CSA) is a c…	Transmedica, Inc.	1997	—

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?

Its one ancestor has no recall.

How does its category compare?

All DQD devices

DQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Read the full statement (180 words)

The Cardiovascular Sonospectrographic Analyzer (CSA) is intended for use in health care environments and setting where conventional stethoscopes (both electronically augmented and non-augmented) and phonocardiographs are used by health care professionals for the auscultation, graphical representation, measurement and archiving of cardiovascular, pulmonary, and other such sounds, both normal and abnormal, as produced by the human body. The CSA is a medical instrument intended for use by, or at the direction of, a qualified health care professional as a diagnostic aid for the clinical assessment and discrimination of acoustic patterns relating to or caused by clinically significant pathologies and medical conditions as known, defined, or specified in standard medical auscultation/phonocardiographic reference textbooks, peer review journals, and medically approved auscultation training materials. The CSA is further intended for the monitoring of interventional or prophylactic therapies that are susceptible to the level of medical efficacy provided by CSA and as is clinically indicated at the discretion of the physician. The CSA is also intended for use in telemedical applications where secondary analysis and options by non-local medical acoustic experts are indicated or desired.

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/K023759 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023759: Cardiovascular Sonospectrographic Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023759

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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