510(k) · Cleared
ClearedSereno Electronic Stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pishon High Tech Co., Ltd. · DQD Stethoscope, Electronic
Cleared on Oct 16, 2006 as substantially equivalent to K003723 (3M Company, 2001) and 1 other predicate after a 53-day review. Its family tree reaches back 4 generations to 1977. 1 later device descends from it.
- Decided
- Oct 16, 2006
- Review
- 53 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K771653 (1977). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK771653 Electronic Stethoscope3M Company · 1977
- 3 generations backK961857 Labtron Electromax Electronic Stethoscope Model NO. 04-1060Graham-Field, Inc. · 1996
- 2 generations backK991367 Meditron Stethoscope SystemMeditron AS · 1999
- 1 generation backK031446 Jabes Electronic StethoscopeGs Technology Co., Ltd. · 2003
- This deviceK062481 Sereno Electronic StethoscopePishon High Tech Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK082528 Snor-Scope Plus or Snor-Scope + Electronic Stethoscope SystemNoble Anesthesia-Air, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K082528Snor-Scope Plus or Snor-Scope + Electronic Stethoscope SystemNoble Anesthesia-Air, Inc. · 2009 · cites it directly0descendants
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 | K961857 | Labtron Electromax Electronic Stethoscope Model NO. 04-1060 | Graham-Field, Inc. | 1996 | — |
| −2 | K991367 | Meditron Stethoscope System | Meditron AS | 1999 | — |
| −1 | K031446 | Jabes Electronic Stethoscope | Gs Technology Co., Ltd. | 2003 | — |
| 0 (this device) | K062481 | Sereno Electronic Stethoscope | Pishon High Tech Co., Ltd. | 2006 | — |
| +1 | K082528 | Snor-Scope Plus or Snor-Scope + Electronic Stethoscope System | Noble Anesthesia-Air, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (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 |
|---|---|---|---|
| * | K003723 | 3M LittmannSummary page 1…me: Electronic Stethoscope, Product code DQD Common/Usual Name: Electronic Stethoscope 2. Equivalent legally marketed devices 3MTM LittmannTm Electronic Stethoscope (K003723), JABES Electronic stethoscope (k03 1446) 3. Indications for Use (intended use) The SERENO Electronic Stethoscope is intended… | 2001 |
| * | K031446 | Jabes Electronic StethoscopeSummary page 1…D Common/Usual Name: Electronic Stethoscope 2. Equivalent legally marketed devices 3MTM LittmannTm Electronic Stethoscope (K003723), JABES Electronic stethoscope (k03 1446) 3. Indications for Use (intended use) The SERENO Electronic Stethoscope is intended for medical diagnostic purposes only. It… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082528 | Snor-Scope Plus or Snor-Scope + Electronic Stethoscope System | 2009 | 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 29 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K082528 (Noble Anesthesia-Air, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K003723.
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 SERENO Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062481: Sereno 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/K062481
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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