510(k) · Cleared
ClearedRNK Telephonic Stethoscope, Model TR-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rnk Products · DQD Stethoscope, Electronic
Cleared on Mar 10, 2004 as substantially equivalent to K963678 (American Telecare, Inc., 1997) and 1 other predicate after a 72-day review. Its family tree reaches back 3 generations to 1996. 32 later devices descend from it.
- Decided
- Mar 10, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K952882 (1996). 4 ancestors in all. 32 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 2 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- 1 generation backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- This deviceK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- Descendant · cites it directly · 29 of its ownK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- Descendant · cites it directly · 26 of its ownK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- Descendant · 2 generations on · 21 of its ownK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- Descendant · 3 generations on · 19 of its ownK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
- Descendant · 4 generations on · 13 of its ownK200776 Eko COREEko Devices, Inc. · 2020
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K072026RNK Electronic StethoscopeRnk Products, Inc. · 2007 · cites it directly29descendants
- K102893PCP/PC StethoscopeRnk Products, Inc. · 2011 · cites it directly26descendants
- K160401Tyto StethoscopeTyto Care, Ltd. · 2016 · 2 generations on21descendants
- K181612Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018 · 3 generations on19descendants
- K200776Eko COREEko Devices, Inc. · 2020 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −2 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| −1 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| 0 (this device) | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| +1 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| +1 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| +2 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| +3 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
| +4 | K200776 | Eko CORE | Eko Devices, Inc. | 2020 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K963678 | Caretone IISummary page 2…electronics Module is The RNK Telephonic Stethoscope TR-1 is substantially equivalent to American TeleCare’s CareTone II Digital TelePhonic Stethoscope (K963678) and American TeleCare’s CareTone II/LBR TelePhonic Stethoscope (marketed as the CareTone Ultra) which was included with the Digi… | 1997 |
| * | K973873 | Digital Personal Telemedicine Module, Digital PTM 1Summary page 2…TelePhonic Stethoscope (K963678) and American TeleCare’s CareTone II/LBR TelePhonic Stethoscope (marketed as the CareTone Ultra) which was included with the Digital PTM (K973873). The RNK Telephonic Stethoscope TR-1 has the same intended use, principles of operation and technological characteristics as th… | 1997 |
What descends from it? (32)
See all 324 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 8 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072026 (Rnk Products, Inc., 2007) has gone furthest, with 29 descendants of its own.
- 2 other devices also cite its predicate K963678.
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 RNK Telephonic Stethoscope Model TR-1 is intended for use to transmit auscultation sounds, whereby a clinician at one location can listen to the auscultation sounds of a patient at a different location with the signal carried over a data communications channel between the two locations.
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/K034046 · printed Nov 4, 2026
Cite this page
510(k) Report. “K034046: RNK Telephonic Stethoscope, Model TR-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K034046
Report an extraction error
Are you the manufacturer?
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