510(k) · Cleared
ClearedJabes Electronic Stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gs Technology Co., Ltd. · DQD Stethoscope, Electronic
Cleared on Oct 31, 2003 as substantially equivalent to K003723 (3M Company, 2001) and 1 other predicate after a 177-day review. Its family tree reaches back 3 generations to 1977. 3 later devices descend from it.
- Decided
- Oct 31, 2003
- Review
- 177 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K771653 (1977). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK771653 Electronic Stethoscope3M Company · 1977
- 2 generations backK961857 Labtron Electromax Electronic Stethoscope Model NO. 04-1060Graham-Field, Inc. · 1996
- 1 generation backK991367 Meditron Stethoscope SystemMeditron AS · 1999
- This deviceK031446 Jabes Electronic StethoscopeGs Technology Co., Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK062481 Sereno Electronic StethoscopePishon High Tech Co., Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK082528 Snor-Scope Plus or Snor-Scope + Electronic Stethoscope SystemNoble Anesthesia-Air, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK062364 I-Scope 200Dongjin Medical Co., Ltd. · 2006
Most influential descendants
Showing 3 of 3 · See all- K062481Sereno Electronic StethoscopePishon High Tech Co., Ltd. · 2006 · cites it directly1descendant
- K082528Snor-Scope Plus or Snor-Scope + Electronic Stethoscope SystemNoble Anesthesia-Air, Inc. · 2009 · 2 generations on0descendants
- K062364I-Scope 200Dongjin Medical Co., Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −2 | K961857 | Labtron Electromax Electronic Stethoscope Model NO. 04-1060 | Graham-Field, Inc. | 1996 | — |
| −1 | K991367 | Meditron Stethoscope System | Meditron AS | 1999 | — |
| 0 (this device) | K031446 | Jabes Electronic Stethoscope | Gs Technology Co., Ltd. | 2003 | — |
| +1 | K062481 | Sereno Electronic Stethoscope | Pishon High Tech Co., Ltd. | 2006 | — |
| +2 | K082528 | Snor-Scope Plus or Snor-Scope + Electronic Stethoscope System | Noble Anesthesia-Air, Inc. | 2009 | — |
| +1 | K062364 | I-Scope 200 | Dongjin Medical Co., Ltd. | 2006 | — |
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 |
|---|---|---|
| 2006 | 2 | 0 |
| 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 CommonKJsualName: Electronic Stethoscope 2. Equivalent legally marketed devices 3MTMLittmannTMElectronic Stethoscope (K003723), Meditron stethoscope system (K99 1347) 3. Indications for Use (intended use) The JABES Electronic Stethoscope is intended for… | 2001 |
| * | K991367 | Meditron Stethoscope System Our reading of the summary gave K991347, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Meditron stethoscope system”. | 1999 |
What descends from it? (3)
2 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?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K062481 (Pishon High Tech Co., Ltd., 2006) has gone furthest, with 1 descendant 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 JABES 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/K031446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031446: Jabes 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/K031446
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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