510(k) · Cleared
ClearedLabtron Electromax Electronic Stethoscope Model NO. 04-1060
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graham-Field, Inc. · DQD Stethoscope, Electronic
Cleared on Jul 3, 1996 as substantially equivalent to K771653 (3M Company, 1977) after a 50-day review. Its family tree reaches back 1 generation to 1977. 54 later devices descend from it.
- Decided
- Jul 3, 1996
- Review
- 50 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K771653 (1977). 54 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK771653 Electronic Stethoscope3M Company · 1977
- This deviceK961857 Labtron Electromax Electronic Stethoscope Model NO. 04-1060Graham-Field, Inc. · 1996
- Descendant · cites it directly · 51 of its ownK991367 Meditron Stethoscope SystemMeditron AS · 1999
- Descendant · 2 generations on · 29 of its ownK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- Descendant · 3 generations on · 26 of its ownK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- Descendant · 4 generations on · 21 of its ownK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- Descendant · 5 generations on · 19 of its ownK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K991367Meditron Stethoscope SystemMeditron AS · 1999 · cites it directly51descendants
- K072026RNK Electronic StethoscopeRnk Products, Inc. · 2007 · 2 generations on29descendants
- K102893PCP/PC StethoscopeRnk Products, Inc. · 2011 · 3 generations on26descendants
- K160401Tyto StethoscopeTyto Care, Ltd. · 2016 · 4 generations on21descendants
- K181612Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| 0 (this device) | K961857 | Labtron Electromax Electronic Stethoscope Model NO. 04-1060 | Graham-Field, Inc. | 1996 | — |
| +1 | K991367 | Meditron Stethoscope System | Meditron AS | 1999 | — |
| +2 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| +3 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| +4 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| +5 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (1)
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 |
|---|---|---|---|
| * | K771653 | Electronic StethoscopeSummary page 1…mmary Prepared: May 6, 1996 Name of the Device: Labtron Electromax Electronic Stethoscope Predicate Device Information: Littmann Brand Electronic Stethoscope 510(k) #K771653, 3M Company, St. Paul, Minnesota Device Description: This electronic stethoscope electronically amplifies sound with fingertip… | 1977 |
What descends from it? (54)
See all 542 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?
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?
For projecting the sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to enhance the acoustical sounds of the device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961857 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961857: Labtron Electromax Electronic Stethoscope Model NO. 04-1060.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961857
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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