510(k) · Cleared
ClearedTyto Stethoscope (G3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyto Care, Ltd. · DQD Stethoscope, Electronic
Cleared on Mar 12, 2026 as substantially equivalent to K181612 (Tyto Care, Ltd., 2018) after a 253-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Mar 12, 2026
- Review
- 253 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K952882 (1996). 22 ancestors in all, the oldest K771653 (1977). No later device cites it as a predicate yet.
- Root · 8 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 7 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- 6 generations backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- 5 generations backK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- 4 generations backK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- 3 generations backK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- 2 generations backK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- 1 generation backK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
- This deviceK252089 Tyto Stethoscope (G3)Tyto Care, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −7 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| −6 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| −5 | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| −4 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| −3 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| −2 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| −1 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
| 0 (this device) | K252089 | Tyto Stethoscope (G3) | Tyto Care, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2018 | 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? (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.
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 3.6 years on median.
- None of the 22 ancestors has a recall.
- 5 other devices also cite its predicate K181612.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto Stethoscope is intended to be used by lay users in non-clinical environments to capture auscultation sounds for transmission to a clinician for review. The Tyto Stethoscope is for medical diagnostics purposes only. The Tyto Stethoscope is not intended for self-diagnosis.
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/K252089 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252089: Tyto Stethoscope (G3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252089
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