510(k) · Cleared
Cleared3M Littmann Electronic Stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minnesota Mining and Mfg. Co. · DQD Stethoscope, Electronic
Cleared on Sep 26, 1997 as substantially equivalent to K771653 (3M Company, 1977) after a 501-day review. Its family tree reaches back 1 generation to 1977. 54 later devices descend from it.
- Decided
- Sep 26, 1997
- Review
- 501 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K771653 (1977). 54 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK771653 Electronic Stethoscope3M Company · 1977
- This deviceK961848 3M Littmann Electronic StethoscopeMinnesota Mining and Mfg. Co. · 1997
- Descendant · cites it directly · 50 of its ownK041934 3M Littmann Electronic Stethoscope, Model 30003M Company · 2004
- Descendant · 2 generations on · 48 of its ownK050159 Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company · 2005
- Descendant · 3 generations on · 46 of its ownK083903 3M Littmann Electronic Stethoscope, Model 32003M Company · 2009
- Descendant · 4 generations on · 21 of its ownK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- Descendant · 3 generations on · 20 of its ownK173448 CliniCloud StethoscopeStethocloud Pty.Ltd (Clinicloud) · 2018
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K0419343M Littmann Electronic Stethoscope, Model 30003M Company · 2004 · cites it directly50descendants
- K050159Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company · 2005 · 2 generations on48descendants
- K0839033M Littmann Electronic Stethoscope, Model 32003M Company · 2009 · 3 generations on46descendants
- K160401Tyto StethoscopeTyto Care, Ltd. · 2016 · 4 generations on21descendants
- K173448CliniCloud StethoscopeStethocloud Pty.Ltd (Clinicloud) · 2018 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| 0 (this device) | K961848 | 3M Littmann Electronic Stethoscope | Minnesota Mining and Mfg. Co. | 1997 | — |
| +1 | K041934 | 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2004 | — |
| +2 | K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2005 | — |
| +3 | K083903 | 3M Littmann Electronic Stethoscope, Model 3200 | 3M Company | 2009 | — |
| +4 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| +3 | K173448 | CliniCloud Stethoscope | Stethocloud Pty.Ltd (Clinicloud) | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 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 |
|---|---|---|---|
| * | K771653 | Electronic StethoscopeSummary page 1…ame of Device: 3M Littmann™ Electronic Stethoscope 5. Predicate Device to which 3M is claiming Substantial Equivalence: 3M Littmann Brand Electronic Stethoscope 510(k) K771653. 6. Intended Use: The 3M Littmann™ Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a pa… | 1977 |
What descends from it? (54)
See all 545 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 is a diagnostic aid and used as part of a physical assessment of a patient by a Health Care Professional. It can be used for the amplification of faint heart, lung and other body sounds as well as normal auscultation and selective frequency filtering. The extended rage mode amplifies sound over a broad range of frequencies, including the range where some lung and prosthetic heart valve sounds occur.
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/K961848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961848: 3M Littmann Electronic Stethoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961848
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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