510(k) · Cleared
Cleared3M Littmann Electronic Stethoscope, Model 4100
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 25, 2005 as substantially equivalent to K003723 (3M Company, 2001) after a 24-day review. Its family tree reaches back 1 generation to 2001. 47 later devices descend from it.
- Decided
- Jul 25, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003723 (2001). 47 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003723 3M Littmann3M Company · 2001
- This deviceK051790 3M Littmann Electronic Stethoscope, Model 41003M Company · 2005
- Descendant · cites it directly · 46 of its ownK083903 3M Littmann Electronic Stethoscope, Model 32003M Company · 2009
- Descendant · 2 generations on · 21 of its ownK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- Descendant · 3 generations on · 19 of its ownK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
- Descendant · 4 generations on · 13 of its ownK200776 Eko COREEko Devices, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK160016 Steth IOStratoscientific, Inc. · 2016
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K0839033M Littmann Electronic Stethoscope, Model 32003M Company · 2009 · cites it directly46descendants
- K160401Tyto StethoscopeTyto Care, Ltd. · 2016 · 2 generations on21descendants
- K181612Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018 · 3 generations on19descendants
- K200776Eko COREEko Devices, Inc. · 2020 · 4 generations on13descendants
- K160016Steth IOStratoscientific, Inc. · 2016 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003723 | 3M Littmann | 3M Company | 2001 | — |
| 0 (this device) | K051790 | 3M Littmann Electronic Stethoscope, Model 4100 | 3M Company | 2005 | — |
| +1 | K083903 | 3M Littmann Electronic Stethoscope, Model 3200 | 3M Company | 2009 | — |
| +2 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| +3 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
| +4 | K200776 | Eko CORE | Eko Devices, Inc. | 2020 | — |
| +2 | K160016 | Steth IO | Stratoscientific, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K003723 | 3M LittmannSummary page 4…(21 CFR § 870.1875(b)) Performance Standards: None 3. Predicate Device: 3MTM Littmann® Electronic Stethoscope, Model 4000 (K003723) 3M Confidential Page VII… | 2001 |
What descends from it? (47)
See all 472 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?
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 3M™ Littmann® Electronic Stethoscope, Model 4100, is intended for medical diagnostic purposes only. It may be used for the detection and ampilification of sounds of the heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency. [t can be used on any person undergoing a physical assessment.
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/K051790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051790: 3M Littmann Electronic Stethoscope, Model 4100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051790
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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