510(k) · Cleared
ClearedDigital Personal Telemedicine Module, Digital PTM 1
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 29, 1997 as substantially equivalent to K964554 (American Telecare, Inc., 1996) and 1 other predicate after an 80-day review. Its family tree reaches back 2 generations to 1996. 36 later devices descend from it.
- Decided
- Dec 29, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K952882 (1996). 3 ancestors in all. 36 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 1 generation backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- This deviceK973873 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
- Descendant · 4 generations on · 19 of its ownK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- 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
- K181612Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −1 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| 0 (this device) | 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 | — |
| +4 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K964554 | Personal Telemedicine ModuleSummary page 1…Usual Name Telemedicine Communications Module Classification Name Powered Communication System Predicate Devices 1. American TeleCare’s Personal Telemedicine Module (K964554); and 2. American TeleCare’s CareTone II Telephonic Stethoscope (K963678) Substantial Equivalence The Digital Te… | 1996 |
| * | K963678 | Caretone IISummary page 1…ed Communication System Predicate Devices 1. American TeleCare’s Personal Telemedicine Module (K964554); and 2. American TeleCare’s CareTone II Telephonic Stethoscope (K963678) Substantial Equivalence The Digital Telemedicine Module (“Digital PTM”) and the predicate devices listed above… | 1997 |
What descends from it? (36)
See all 362 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 1 year and passes through 1 company; a new generation was cleared every 1.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K034046 (Rnk Products, 2004) has gone furthest, with 32 descendants of its own.
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 Digital 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, as well as 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/K973873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973873: Digital Personal Telemedicine Module, Digital PTM 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973873
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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