510(k) · Cleared
ClearedElectronic Stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sharp Corporation · DQD Stethoscope, Electronic
Cleared on Sep 26, 2012 as substantially equivalent to K050159 (3M Company, 2005) and 2 other predicates after a 163-day review. Its family tree reaches back 5 generations to 1977.
- Decided
- Sep 26, 2012
- Review
- 163 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K771653 (1977). 7 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK121144 Electronic StethoscopeSharp Corporation · 2012
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) | K121144 | Electronic Stethoscope | Sharp Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 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? (3)
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 1…ctronic Stethoscope Classification Name: Stethoscope, Electronic Product Code: DQD Classification: Class 11, 21 CER 870.1875 Predicate Device: K050159, K041934 3M Littmann Stethoscope, Model 3 100 K083903 3M Littmann Stethoscope, Model 3200 Device Descript… | 2005 |
| * | K041934 | 3M Littmann Electronic Stethoscope, Model 3000Summary page 1…tethoscope Classification Name: Stethoscope, Electronic Product Code: DQD Classification: Class 11, 21 CER 870.1875 Predicate Device: K050159, K041934 3M Littmann Stethoscope, Model 3 100 K083903 3M Littmann Stethoscope, Model 3200 Device Description: T… | 2004 |
| * | K083903 | 3M Littmann Electronic Stethoscope, Model 3200Summary page 1…Code: DQD Classification: Class 11, 21 CER 870.1875 Predicate Device: K050159, K041934 3M Littmann Stethoscope, Model 3 100 K083903 3M Littmann Stethoscope, Model 3200 Device Description: The Sharp Electronic Stethoscope Model BM-520 is an electronic stetho… | 2009 |
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.
What does this lineage say?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 7 ancestors has a recall.
- 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. 2012, 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 BM-520 Electronic Stethoscope is intended for medical diagnosticpurposes only. It may be used for the detection and amplification of sounds from heart, lungs, blood vessels, and other internal organs. It can be used on any person undergoing a physical assessment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121144: 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/K121144
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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