510(k) · Cleared
ClearedRNK Electronic Stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rnk Products, Inc. · DQD Stethoscope, Electronic
Cleared on Oct 26, 2007 as substantially equivalent to K034046 (Rnk Products, 2004) and 1 other predicate after a 94-day review. Its family tree reaches back 4 generations to 1996. 29 later devices descend from it.
- Decided
- Oct 26, 2007
- Review
- 94 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K952882 (1996). 11 ancestors in all, the oldest K771653 (1977). 29 later devices descend from it, 3 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 backK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- This deviceK072026 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
- Descendant · 2 generations on · 3 of its ownK132560 PCP-Usb StethoscopeRnk Products, Inc. · 2013
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- 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
- K132560PCP-Usb StethoscopeRnk Products, Inc. · 2013 · 2 generations on3descendants
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 | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| 0 (this device) | 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 | — |
| +2 | K132560 | PCP-Usb Stethoscope | Rnk Products, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 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 |
|---|---|---|---|
| * | K034046 | RNK Telephonic Stethoscope, Model TR-1 Our reading of the summary gave K030446, FDA’s number for Repicci Locked Keel Tibial Bearing (Biomet, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “RNK Products TR-1”. | 2004 |
| * | K991367 | Meditron Stethoscope SystemSummary page 1…Name Electronic Stethoscope Predicate Devices RNK Products TR-1 (K030446) and Meditron Stethoscope (K991367) Device Description The RNK Electronic Stethoscope is comprised of a Chest Piece assembly, an Amplifier module containing an amp… | 1999 |
What descends from it? (29)
See all 293 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 11 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K102893 (Rnk Products, Inc., 2011) has gone furthest, with 26 descendants of its own.
- 3 other devices also cite its predicate K034046.
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 RNK Electronic Stethoscope is intended for use in detecting and amplifying heart, lung and other body sounds for diagnostic or monitoring purposes on any patient undergoing a physical assessment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072026 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072026: RNK Electronic Stethoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072026
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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