510(k) · Cleared
ClearedCaretone II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Telecare, Inc. · DQD Stethoscope, Electronic
Cleared on Feb 24, 1997 after a 164-day review. The FDA summary names its predicate without a number. 46 later devices descend from it.
- Decided
- Feb 24, 1997
- Review
- 164 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 0
46 later devices descend from it, 3 citing it directly.
- This deviceK963678 Caretone IIAmerican Telecare, Inc. · 1997
- Descendant · cites it directly · 36 of its ownK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- Descendant · cites it directly · 32 of its ownK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- Descendant · 2 generations on · 29 of its ownK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- Descendant · 2 generations on · 26 of its ownK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- Descendant · 3 generations on · 21 of its ownK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K973873Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997 · cites it directly36descendants
- K034046RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004 · cites it directly32descendants
- K072026RNK Electronic StethoscopeRnk Products, Inc. · 2007 · 2 generations on29descendants
- K102893PCP/PC StethoscopeRnk Products, Inc. · 2011 · 2 generations on26descendants
- K160401Tyto StethoscopeTyto Care, Ltd. · 2016 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963678 | Caretone II | American Telecare, Inc. | 1997 | — |
| +1 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| +1 | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| +2 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| +2 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| +3 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | CareTone Telephonic Stethoscope Named without a submission number |
What descends from it? (46)
See all 463 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?
- Of its descendants, K973873 (American Telecare, Inc., 1997) has gone furthest, with 36 descendants of its own.
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 intended use of American Telecare, Inc.’s CareTone II is to conduct a stethoscope examination of a patient by a nurse or physician at another location using a communications line.
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/K963678 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963678: Caretone II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963678
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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