510(k) · Cleared
ClearedMyHomeDoc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myhomedoc, Ltd. · DQD Stethoscope, Electronic
Cleared on Mar 23, 2021 as substantially equivalent to K040178 (S.P.O. Medical Equipment, Ltd., 2004) and 2 other predicates after a 207-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it.
- Decided
- Mar 23, 2021
- Review
- 207 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K952882 (1996). 39 ancestors in all, the oldest K771653 (1977). 1 later device descends from it, 1 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 deviceK202483 MyHomeDocMyhomedoc, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK223785 N9+Nonagon, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223785N9+Nonagon, Ltd. · 2023 · cites it directly0descendants
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) | K202483 | MyHomeDoc | Myhomedoc, Ltd. | 2021 | — |
| +1 | K223785 | N9+ | Nonagon, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K040178 | Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceSummary page 4…vice is substantially equivalent to the following predicate devices: • Pulse Oximeter- PulseOx 5500 Finger Device, manufactured by SPO Medical Ltd cleared under K040178, Classification name: Oximeter, Product code: DQA, Regulation: 21 CFR 870.2700 K202483… | 2004 |
| * | K160401 | Tyto StethoscopeSummary page 5…5 === MyHomeDoc Ltd. Traditional 510(k) – MyHomeDoc device • Stethoscope- Tyto Stethoscope manufactured by Tyto care Ltd. cleared under K160401, Classification name Electronic stethoscope, Product code: DQD, Regulation: 21 CFR 870.1875 • Thermometer- Braun No To… | 2016 |
| * | K163516 | Braun No Touch + Forehead NTF3000 ThermometerSummary page 5…Product code: DQD, Regulation: 21 CFR 870.1875 • Thermometer- Braun No Touch + Forehead NTF3000 Thermometer, manufactured by Kaz USA, Inc, cleared under K163516, Classification: Clinical Electronic Thermometer, Product code: FLL, Regulation: 21 CFR 880.2910 In addition, the followin… | 2017 |
| † | K101834 | 3M Littmann Scope-to Scope Software System | 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 |
|---|---|---|---|
| K223785 | N9+ | 2023 | 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 25 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 39 ancestors have a recall of any class.
- Of its descendants, K223785 (Nonagon, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K040178.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 MyHomeDoc device, combined with a smartphone application, is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound of human body, human body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part.
MyHomeDoc device is intended for use by adult lay users in a non-clinical environment. MyHomeDoc application enables counseling with the physician and transmission of the information over an IP network.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202483: MyHomeDoc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202483
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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