510(k) · Cleared
ClearedPersonal Telemedicine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Telecare, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 9, 1996 after a 444-day review. The FDA summary names its predicate without a number. 142 later devices descend from it.
- Decided
- Sep 9, 1996
- Review
- 444 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
142 later devices descend from it, 3 citing it directly.
- This deviceK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- Descendant · cites it directly · 103 of its ownK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- Descendant · 2 generations on · 98 of its ownK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- Descendant · 2 generations on · 90 of its ownK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- Descendant · 2 generations on · 86 of its ownK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- Descendant · 3 generations on · 59 of its ownK041816 RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004
Showing 5 of 142 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 142 · See all- K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard Co. · 1999 · cites it directly103descendants
- K023749The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Philips Medical Systems · 2002 · 2 generations on98descendants
- K031840Carematix Wellness SystemCarematix, Inc. · 2003 · 2 generations on90descendants
- K040966Modification to Carematix Wellness SystemCarematix, Inc. · 2004 · 2 generations on86descendants
- K041816RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004 · 3 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| +1 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| +2 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| +2 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| +2 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| +3 | K041816 | RTX3320PSTN Wireless Telehealth Gateway | Rtx Healthcare A/S | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 11 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 15 | 0 |
| 2010 | 11 | 0 |
| 2011 | 11 | 0 |
| 2012 | 7 | 0 |
| 2013 | 15 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 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 |
|---|---|---|---|
| * | — | Digital Blood Pressure Monitor Named without a submission number | |
| * | — | TelePhonic Stethoscope Named without a submission number | |
| * | — | Image Management System and Corabi DX2000 Dynamic Module Named without a submission number |
What descends from it? (142)
See all 1423 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, K993169 (Hewlett-Packard Co., 1999) has gone furthest, with 103 descendants of its own.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The American TeleCare, Inc. Personal Telemedicine System (PTS) is intended to be used to transmit medical information between a patient at one location, typically in their home, and a medical practitioner at another location, typically a home care nurse at a central nursing station. Information is transmitted over normal residential telephone lines and utilizes two-way video and voice communication. The PTS is typically used in home health care…
Read the full statement (118 words)
The American TeleCare, Inc. Personal Telemedicine System (PTS) is intended to be used to transmit medical information between a patient at one location, typically in their home, and a medical practitioner at another location, typically a home care nurse at a central nursing station. Information is transmitted over normal residential telephone lines and utilizes two-way video and voice communication.
The PTS is typically used in home health care situations as an augment to home care nursing.
In essence, the PTS allows a medical practitioner to make a "video-visit"™ to the patient rather than a physical visit. In this "video-visit," the medical practitioner can conduct many of the same diagnostic tests that would be performed in a physical visit.
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/K952882 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952882: Personal Telemedicine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952882
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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