510(k) · Cleared

Cleared

Stethos, Model Stxxyyzz or 001 XXX, Stethos Link, Model Slxxyyzz or 002 XXX

K001306510(k) TraditionalCleared Jul 20, 200086-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

Andromed, Inc. · DQD Stethoscope, Electronic

Cleared on Jul 20, 2000 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided: Jul 20, 2000
Review: 86 days
Class: Class II
Product code: DQD
Recalls: None
Predicates: 0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K001306Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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.

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	—

https://510kreport.com/device/K001306 · printed Nov 4, 2026

Cite this page

510(k) Report. “K001306: Stethos, Model Stxxyyzz or 001 XXX, Stethos Link, Model Slxxyyzz or 002 XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001306

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026