510(k) · Cleared
ClearedI-Scope 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dongjin Medical Co., Ltd. · DQD Stethoscope, Electronic
Cleared on Dec 6, 2006 as substantially equivalent to K003723 (3M Company, 2001) and 1 other predicate after a 114-day review. Its family tree reaches back 4 generations to 1977.
- Decided
- Dec 6, 2006
- Review
- 114 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. No later device cites it as a predicate yet.
- 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 deviceK062364 I-Scope 200Dongjin Medical Co., Ltd. · 2006
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) | 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 |
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…device, i-Scope 200, is substantially equivalent in technical characteristics and intended used to: - 3M Littmann Electronic stethoscope, Model 4000(K003723) - JABES electronic stethoscope(K03 1446) Device Description i-scope 200 digital stethoscope is a new advanc… | 2001 |
| * | K031446 | Jabes Electronic StethoscopeSummary page 1…technical characteristics and intended used to: - 3M Littmann Electronic stethoscope, Model 4000(K003723) - JABES electronic stethoscope(K03 1446) Device Description i-scope 200 digital stethoscope is a new advanced product compared to conventional stethoscope… | 2003 |
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 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.
- 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 i-Scope 200 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/K062364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062364: I-Scope 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062364
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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