510(k) · Cleared
Cleared3M Littmann Electronic Stethoscope, Model 3200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · DQD Stethoscope, Electronic
Cleared on Jul 15, 2009 as substantially equivalent to K050159 (3M Company, 2005) and 1 other predicate after a 198-day review. Its family tree reaches back 4 generations to 1977. 46 later devices descend from it.
- Decided
- Jul 15, 2009
- Review
- 198 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K771653 (1977). 6 ancestors in all. 46 later devices descend from it, 17 citing it directly.
- Root · 4 generations backK771653 Electronic Stethoscope3M Company · 1977
- 3 generations backK961848 3M Littmann Electronic StethoscopeMinnesota Mining and Mfg. Co. · 1997
- 2 generations backK041934 3M Littmann Electronic Stethoscope, Model 30003M Company · 2004
- 1 generation backK050159 Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company · 2005
- This deviceK083903 3M Littmann Electronic Stethoscope, Model 32003M Company · 2009
- Descendant · cites it directly · 21 of its ownK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- Descendant · 2 generations on · 19 of its ownK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
- Descendant · 3 generations on · 13 of its ownK200776 Eko COREEko Devices, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK160016 Steth IOStratoscientific, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK222871 Stethophone v1Sparrow Acoustics, Inc. · 2023
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K160401Tyto StethoscopeTyto Care, Ltd. · 2016 · cites it directly21descendants
- K181612Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018 · 2 generations on19descendants
- K200776Eko COREEko Devices, Inc. · 2020 · 3 generations on13descendants
- K160016Steth IOStratoscientific, Inc. · 2016 · cites it directly4descendants
- K222871Stethophone v1Sparrow Acoustics, Inc. · 2023 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −3 | K961848 | 3M Littmann Electronic Stethoscope | Minnesota Mining and Mfg. Co. | 1997 | — |
| −2 | K041934 | 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2004 | — |
| −1 | K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2005 | — |
| 0 (this device) | K083903 | 3M Littmann Electronic Stethoscope, Model 3200 | 3M Company | 2009 | — |
| +1 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| +2 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
| +3 | K200776 | Eko CORE | Eko Devices, Inc. | 2020 | — |
| +1 | K160016 | Steth IO | Stratoscientific, Inc. | 2016 | — |
| +1 | K222871 | Stethophone v1 | Sparrow Acoustics, Inc. | 2023 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000Summary page 2…at 3MTM Littmann® Electronic Stethoscope, Model 3200 is substantially equivalent to the predicate device 3MTM Littmann® Electronic Stethoscope, Model 3000, cleared under K050159 and Littmann® Electronic Stethoscope, Model 4100, cleared under K051790 in terms of intended use, indications for use, compositio… | 2005 |
| * | K051790 | 3M Littmann Electronic Stethoscope, Model 4100Summary page 2…uivalent to the predicate device 3MTM Littmann® Electronic Stethoscope, Model 3000, cleared under K050159 and Littmann® Electronic Stethoscope, Model 4100, cleared under K051790 in terms of intended use, indications for use, composition, physical properties and technological characteristics. There are no n… | 2005 |
What descends from it? (46)
See all 4617 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160401 | Tyto Stethoscope | 2016 | 21 |
| K160016 | Steth IO | 2016 | 4 |
| K222871 | Stethophone v1 | 2023 | 3 |
| K160023 | Electronic Stethoscope DS301 | 2016 | 3 |
| K221805 | AccurSound Electronic Stethoscope AS-101 | 2023 | 2 |
| K203007 | eKuore Pro Series | 2020 | 2 |
| K172296 | Stethee Pro | 2017 | 2 |
| K252076 | Kneevoice Cartilage Evaluation System (750-3600-001) | 2026 | 0 |
| K212709 | VoqX Electronic Stethoscope | 2022 | 0 |
| K191667 | Electronic Stethoscope | 2019 | 0 |
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 32 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K160401 (Tyto Care, Ltd., 2016) has gone furthest, with 21 descendants of its own.
- 2 other devices also cite its predicate K050159.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 3M Littmann® Electronic Stethoscope, Model 3200 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083903 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083903: 3M Littmann Electronic Stethoscope, Model 3200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083903
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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