510(k) · Cleared
ClearedPersonal Telemedicine Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Telecare, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Dec 17, 1996 as substantially equivalent to K952882 (American Telecare, Inc., 1996) after a 34-day review. Its family tree reaches back 1 generation to 1996. 37 later devices descend from it.
- Decided
- Dec 17, 1996
- Review
- 34 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952882 (1996). 37 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- This deviceK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- Descendant · cites it directly · 36 of its ownK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- Descendant · 2 generations on · 32 of its ownK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- Descendant · 3 generations on · 29 of its ownK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- Descendant · 3 generations on · 26 of its ownK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- Descendant · 4 generations on · 21 of its ownK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K973873Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997 · cites it directly36descendants
- K034046RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004 · 2 generations on32descendants
- K072026RNK Electronic StethoscopeRnk Products, Inc. · 2007 · 3 generations on29descendants
- K102893PCP/PC StethoscopeRnk Products, Inc. · 2011 · 3 generations on26descendants
- K160401Tyto StethoscopeTyto Care, Ltd. · 2016 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| 0 (this device) | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| +1 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| +2 | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| +3 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| +3 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| +4 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K952882 | Personal Telemedicine SystemSummary page 1…e Powered Communication System Common Name Telemedicine Communications Module Pruduct Codc ILC Predicate Device American Telecare Inc.’s Personal Telemedicine System (K952882) Intended Use American Telecare, Inc.’s Personal Telemedicine Module (“PTM 17) 1s intended to be used solely as a monitoring dcv… | 1996 |
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | 1997 | 36 |
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?
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Personal Telemedicine Module is intended to be used solely as a monitoring device, whereby a health care professional can communicate with the patient between visits to gather blood pressure and pulse readings, and to listen to the patient's heart and lung sounds.
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/K964554 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964554: Personal Telemedicine Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964554
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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