510(k) · Cleared
ClearedCarestation 126S Videophone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Motion Media Technology, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Oct 10, 2003 as substantially equivalent to K020584 (Neptec Design Group, Ltd., 2002) and 2 other predicates after a 116-day review. Its family tree reaches back 3 generations to 1998. 10 later devices descend from it.
- Decided
- Oct 10, 2003
- Review
- 116 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K981533 (1998). 6 ancestors in all, the oldest K963678 (1997). 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK981533 Aviva Systems Model Numbers 1010, 2020American Telecare, Inc. · 1998
- 2 generations backK012801 N2000 Base Station, N2001 Nurse StationNeptec Design Group, Ltd. · 2001
- 1 generation backK020584 N2000 Base Station; N2001 Nurse StationNeptec Design Group, Ltd. · 2002
- This deviceK031863 Carestation 126S VideophoneMotion Media Technology, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK052608 Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK073710 Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies · 2008
- Descendant · 3 generations on · 1 of its ownK131739 Nxstage Connected Health SystemNxstage Medical, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK120895 Remote Presence SystemIntouch Health, Inc. · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K052608Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006 · cites it directly5descendants
- K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010 · 2 generations on4descendants
- K073710Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies · 2008 · cites it directly2descendants
- K131739Nxstage Connected Health SystemNxstage Medical, Inc. · 2013 · 3 generations on1descendant
- K120895Remote Presence SystemIntouch Health, Inc. · 2012 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981533 | Aviva Systems Model Numbers 1010, 2020 | American Telecare, Inc. | 1998 | — |
| −2 | K012801 | N2000 Base Station, N2001 Nurse Station | Neptec Design Group, Ltd. | 2001 | — |
| −1 | K020584 | N2000 Base Station; N2001 Nurse Station | Neptec Design Group, Ltd. | 2002 | — |
| 0 (this device) | K031863 | Carestation 126S Videophone | Motion Media Technology, Inc. | 2003 | — |
| +1 | K052608 | Telephone Based BL Healthcare Remote Care Management System (RCMS) | Bl Healthcare, Inc. | 2006 | — |
| +2 | K093379 | TCX-I-DV Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +1 | K073710 | Intouch Remote Presence Robotic System, Model RP-7 | Intouch Technologies | 2008 | — |
| +3 | K131739 | Nxstage Connected Health System | Nxstage Medical, Inc. | 2013 | — |
| +2 | K120895 | Remote Presence System | Intouch Health, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K020584 | N2000 Base Station; N2001 Nurse StationSummary page 2…transmission of patient vital signs information from external measurement devices, it is equivalent to the Carecompanion Nurse Station / Care Companion Patient Station (#K020584). With respect to the integrated electronic stethoscope, it is equivalent to the CareTone I1 Telephonic Stethoscope (#K963678). W… | 2002 |
| * | K963678 | Caretone IISummary page 2…Station / Care Companion Patient Station (#K020584). With respect to the integrated electronic stethoscope, it is equivalent to the CareTone I1 Telephonic Stethoscope (#K963678). With respect to the pulse oximetry accessory, it is equivalent to the Zymed Easi-View Telemetry System (#K001308). In addition… | 1997 |
| * | K001308 | Modification to Zymed Telemetry System, Model EasiviewSummary page 2…equivalent to the CareTone I1 Telephonic Stethoscope (#K963678). With respect to the pulse oximetry accessory, it is equivalent to the Zymed Easi-View Telemetry System (#K001308). In addition, the following devices can be used with the Carestation system to provide the external vital signs monitoring func… | 2000 |
What descends from it? (10)
3 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 5 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K052608 (Bl Healthcare, Inc., 2006) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K020584.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The Carestation CS 126s is intended to be used upon prescription of an authorized healthcare provider by patients to provide two-way video, audio, and data communications including patient vital signs information over standard telephone lines between the patient, typically at home, and a health care professional at the health care provider’s site. The information includes heart, lung, and bowel sounds, blood oxygen saturation, pulse rate, blood pressure…
Read the full statement (141 words)
The Carestation CS 126s is intended to be used upon prescription of an authorized
healthcare provider by patients to provide two-way video, audio, and data
communications including patient vital signs information over standard telephone lines
between the patient, typically at home, and a health care professional at the health care
provider’s site.
The information includes heart, lung, and bowel sounds, blood oxygen saturation, pulse
rate, blood pressure, temperature, blood glucose, weight, and breath peak flow
measurements. The information is collected upon the request and direction of the health
care provider.
The device does not send any real-time alarms. The device is a diagnostic aid. Clinical
judgment and experience are required to check and interpret the information transmitted.
The device is not intended as a substitute for medical care. The device is contraindicated
for patients requiring direct medical supervision or emergency intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031863: Carestation 126S Videophone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031863
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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