510(k) · Cleared
Cleared3M Littmann Telesteth Online Ausculation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on May 3, 2012 as substantially equivalent to K101834 (3M Company, 2010) after a 56-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- May 3, 2012
- Review
- 56 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K952882 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 3 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- 2 generations backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- 1 generation backK101834 3M Littmann Scope-to Scope Software System3M Company · 2010
- This deviceK120704 3M Littmann Telesteth Online Ausculation System3M Company · 2012
- Descendant · cites it directly · 0 of its ownK171188 Ossler Exam ScopeLr Med, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K171188Ossler Exam ScopeLr Med, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −3 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| −2 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| −1 | K101834 | 3M Littmann Scope-to Scope Software System | 3M Company | 2010 | — |
| 0 (this device) | K120704 | 3M Littmann Telesteth Online Ausculation System | 3M Company | 2012 | — |
| +1 | K171188 | Ossler Exam Scope | Lr Med, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K101834 | 3M Littmann Scope-to Scope Software SystemSummary page 1…radiofrequency (21 CFR § 870.2910) Performance Standards: None Predicate Device: 3M"W Littmann® SCOPe-to-SCOPC. Soft%%areSystem (K101834 3M Health Care) 510(k) Pmararket Notification for 3MTm Littmannt TeleSteth Online Auscultation System D… | 2010 |
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 |
|---|---|---|---|
| K171188 | Ossler Exam Scope | 2017 | 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 16 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K171188 (Lr Med, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The 3M Littmann TeleSteth Online Auscultation System is intended to provide and control the real time data transfer of body sounds between two 3M Littmann Electronic Stethoscopes Model 3200 over a data network. Patient body sounds may be remotely evaluated in real-time or in store-and-forward mode. The 3M Littmann TeleSteth Online Auscultation System can be used on any person undergoing a physical assessment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120704 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120704: 3M Littmann Telesteth Online Ausculation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120704
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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