510(k) · Cleared
ClearedElectronic Stethoscope DS301
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imediplus, Inc. · DQD Stethoscope, Electronic
Cleared on Sep 30, 2016 as substantially equivalent to K083903 (3M Company, 2009) after a 268-day review. Its family tree reaches back 5 generations to 1977. 3 later devices descend from it.
- Decided
- Sep 30, 2016
- Review
- 268 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K771653 (1977). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK771653 Electronic Stethoscope3M Company · 1977
- 4 generations backK961848 3M Littmann Electronic StethoscopeMinnesota Mining and Mfg. Co. · 1997
- 3 generations backK041934 3M Littmann Electronic Stethoscope, Model 30003M Company · 2004
- 2 generations backK050159 Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company · 2005
- 1 generation backK083903 3M Littmann Electronic Stethoscope, Model 32003M Company · 2009
- This deviceK160023 Electronic Stethoscope DS301Imediplus, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK173663 Electronic Stethoscope DS3011AImediplus, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK220466 ibiomedi Electronic Stethoscope ES-2020Sound Land Corp. · 2022
- Descendant · 2 generations on · 0 of its ownK182196 Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic…Imediplus, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K173663Electronic Stethoscope DS3011AImediplus, Inc. · 2018 · cites it directly1descendant
- K220466ibiomedi Electronic Stethoscope ES-2020Sound Land Corp. · 2022 · cites it directly0descendants
- K182196Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model…Imediplus, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −4 | K961848 | 3M Littmann Electronic Stethoscope | Minnesota Mining and Mfg. Co. | 1997 | — |
| −3 | K041934 | 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2004 | — |
| −2 | K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2005 | — |
| −1 | K083903 | 3M Littmann Electronic Stethoscope, Model 3200 | 3M Company | 2009 | — |
| 0 (this device) | K160023 | Electronic Stethoscope DS301 | Imediplus, Inc. | 2016 | — |
| +1 | K173663 | Electronic Stethoscope DS3011A | Imediplus, Inc. | 2018 | — |
| +1 | K220466 | ibiomedi Electronic Stethoscope ES-2020 | Sound Land Corp. | 2022 | — |
| +2 | K182196 | Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope… | Imediplus, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K083903 | 3M Littmann Electronic Stethoscope, Model 3200Summary page 6…Number IMEDIPLUS 3MTM LITTMANN® Electronic ELECTRONIC 3M COMPANY K083903 Stethoscope DS301 STETHOSCOPE MODEL 3200 III. DEVICE Common Name and… | 2009 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 39 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K173663 (Imediplus, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 16 other devices also cite its predicate K083903.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 IMEDIPLUS Electronic Stethoscope DS301 is intended for the detection, amplification and recording of sounds from
the heart, lung, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective
frequency ranges. And the stethoscope chest-piece is designed for use with child, adolescent and adult patients. It is used
for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160023: Electronic Stethoscope DS301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160023
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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