510(k) · Cleared
ClearedTyto Stethoscope (OTC)
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 Dec 17, 2018 as substantially equivalent to K160401 (Tyto Care, Ltd., 2016) and 1 other predicate after a 181-day review. Its family tree reaches back 7 generations to 1996. 19 later devices descend from it.
- Decided
- Dec 17, 2018
- Review
- 181 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K952882 (1996). 21 ancestors in all, the oldest K771653 (1977). 19 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 6 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- 5 generations backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- 4 generations backK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- 3 generations backK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- 2 generations backK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- 1 generation backK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- This deviceK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
- Descendant · cites it directly · 13 of its ownK200776 Eko COREEko Devices, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK231551 StethophoneSparrow Acoustics, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK210736 doctorgram Stethoscope DES-IGv Concepts · 2021
- Descendant · 3 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK212975 MedWandMedwand Solutions, Inc. · 2022
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K200776Eko COREEko Devices, Inc. · 2020 · cites it directly13descendants
- K231551StethophoneSparrow Acoustics, Inc. · 2023 · 2 generations on2descendants
- K210736doctorgram Stethoscope DES-IGv Concepts · 2021 · 2 generations on2descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 3 generations on1descendant
- K212975MedWandMedwand Solutions, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −6 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| −5 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| −4 | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| −3 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| −2 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| −1 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| 0 (this device) | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
| +1 | K200776 | Eko CORE | Eko Devices, Inc. | 2020 | — |
| +2 | K231551 | Stethophone | Sparrow Acoustics, Inc. | 2023 | — |
| +2 | K210736 | doctorgram Stethoscope DES-I | Gv Concepts | 2021 | — |
| +3 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
| +3 | K212975 | MedWand | Medwand Solutions, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 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 |
|---|---|---|---|
| * | K160401 | Tyto StethoscopeSummary page 4…Panel: Cardiovascular Predicate Device(s): Primary: Device name 510(k) No. Date of Clearance Tyto Stethoscope K160401 October 19, 2016 1 ===… | 2016 |
| * | K173448 | CliniCloud StethoscopeSummary page 5…Page 2 of 4 The OTC use of an electronic stethoscope is supported by a second predicate, the CliniCloud Stethoscope (K173448) which is similarly cleared for over the counter use in periodic recording of lung and heart sounds. Secondary: Device name… | 2018 |
| † | K102893 | PCP/PC Stethoscope | 2011 |
| † | K083903 | 3M Littmann Electronic Stethoscope, Model 3200 | 2009 |
What descends from it? (19)
See all 196 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 22 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K200776 (Eko Devices, Inc., 2020) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K160401.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 on site or 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 professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181612: Tyto Stethoscope (OTC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181612
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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