510(k) · Cleared
ClearedI-Stethos Link
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andromed, Inc. · DQD Stethoscope, Electronic
Cleared on Oct 1, 2002 after a 77-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 1, 2002
- Review
- 77 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQD
89in 2025
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 6 | 161 | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 107 | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 70 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 250 | 0 | 0 |
| 2017 | 4 | 109 | 0 | 0 |
| 2018 | 4 | 131 | 0 | 0 |
| 2019 | 4 | 262 | 0 | 0 |
| 2020 | 6 | 104 | 0 | 0 |
| 2021 | 4 | 137 | 0 | 0 |
| 2022 | 8 | 203 | 0 | 0 |
| 2023 | 10 | 132 | 0 | 0 |
| 2024 | 4 | 153 | 0 | 1 |
| 2025 | 3 | 89 | 0 | 0 |
| 2026 | 6 | 236 | 0 | — |
What is it indicated for?
The i-Stethos Link Electronic Stethoscope is intended for the purpose of electronically amplifying and listening to biological sounds, such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The i-Stethos Link may also be used to display the heart rate, which is calculated as the number of heartbeats per minute. In addition, the i-Stethos Link is equipped with an analog 1/0 port to interface with external…
Read the full statement (146 words)
The i-Stethos Link Electronic Stethoscope is intended for the purpose of electronically amplifying and listening to biological sounds, such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The i-Stethos Link may also be used to display the heart rate, which is calculated as the number of heartbeats per minute.
In addition, the i-Stethos Link is equipped with an analog 1/0 port to interface with external devices such as a computer and to accept input from other compatible devices such as the biological sound monitor (BSM) sensor or another i-Stethos Link.
The i-Stethos Link Electronic Stethoscope is indicated for use under the same conditions that would otherwise require the use of an acoustic (non-electronic) stethoscope.
The i-Stethos Link Electronic Stethoscope is not intended as a substitute for medical care or for diagnosis and treatment by unlicensed or unqualified persons.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022298: I-Stethos Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022298
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026