510(k) · Cleared
ClearedAusco ES-3100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koratek Company, Ltd. · DQD Stethoscope, Electronic
Cleared on Nov 6, 2007 as substantially equivalent to K041934 (3M Company, 2004) and 2 other predicates after a 252-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- Nov 6, 2007
- Review
- 252 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K771653 (1977). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK771653 Electronic Stethoscope3M Company · 1977
- 2 generations backK961857 Labtron Electromax Electronic Stethoscope Model NO. 04-1060Graham-Field, Inc. · 1996
- 1 generation backK012304 Adc 656 Electronic StethoscopeAmerican Diagnostic Corp. · 2001
- This deviceK070550 Ausco ES-3100Koratek Company, Ltd. · 2007
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 | K012304 | Adc 656 Electronic Stethoscope | American Diagnostic Corp. | 2001 | — |
| 0 (this device) | K070550 | Ausco ES-3100 | Koratek Company, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K041934 | 3M Littmann Electronic Stethoscope, Model 3000Summary page 1…3(b) of the Food, Drug and Cosmetic Act. 3. Predicate Device(s): 3MTM LITTMANN® Electronic Stethoscope, Model 3000, K041934 3MTM LITTMANN® Electronic Stethoscope, Model 2000, K961848 American Diagnostic Corporation's, Model ADC 656 Electroni… | 2004 |
| * | K961848 | 3M Littmann Electronic StethoscopeSummary page 1…and Cosmetic Act. 3. Predicate Device(s): 3MTM LITTMANN® Electronic Stethoscope, Model 3000, K041934 3MTM LITTMANN® Electronic Stethoscope, Model 2000, K961848 American Diagnostic Corporation's, Model ADC 656 Electronic Stethoscope, K012304 4. Description of Device: The A… | 1997 |
| * | K012304 | Adc 656 Electronic StethoscopeSummary page 1…cope, Model 3000, K041934 3MTM LITTMANN® Electronic Stethoscope, Model 2000, K961848 American Diagnostic Corporation's, Model ADC 656 Electronic Stethoscope, K012304 4. Description of Device: The AUSCO ES-3 100 Electronic Stethoscope is a healthcare device that electronically filters… | 2001 |
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 30 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K041934.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 AUSCO ES-3100 Electronic Stethoscope is intended for medical diagnostic purposes. It may be used for the amplification of sounds associated with the heart, lungs, arteries, veins, 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/K070550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070550: Ausco ES-3100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070550
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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