510(k) · Cleared
ClearedTelecare D.R. Server Software System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthcare Vision, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Apr 13, 2004 as substantially equivalent to K020584 (Neptec Design Group, Ltd., 2002) and 1 other predicate after a 196-day review. Its family tree reaches back 3 generations to 1998. 3 later devices descend from it.
- Decided
- Apr 13, 2004
- Review
- 196 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K981533 (1998). 5 ancestors in all. 3 later devices descend from it, 1 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 deviceK033133 Telecare D.R. Server Software SystemHealthcare Vision, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK073710 Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies · 2008
- Descendant · 2 generations on · 1 of its ownK120895 Remote Presence SystemIntouch Health, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK123229 Remote Presence System, Model RP-VitaIntouch Health, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K073710Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies · 2008 · cites it directly2descendants
- K120895Remote Presence SystemIntouch Health, Inc. · 2012 · 2 generations on1descendant
- K123229Remote Presence System, Model RP-VitaIntouch Health, Inc. · 2012 · 3 generations on0descendants
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) | K033133 | Telecare D.R. Server Software System | Healthcare Vision, Inc. | 2004 | — |
| +1 | K073710 | Intouch Remote Presence Robotic System, Model RP-7 | Intouch Technologies | 2008 | — |
| +2 | K120895 | Remote Presence System | Intouch Health, Inc. | 2012 | — |
| +3 | K123229 | Remote Presence System, Model RP-Vita | Intouch Health, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 2 | 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? (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 |
|---|---|---|---|
| * | K020584 | N2000 Base Station; N2001 Nurse StationSummary page 3…the transmission of patient vital signs information from external measurement devices, it is equivalent to the Carecompanion Nurse Station/Carecompanion Patient Station (K020584). With respect to the pulse oximetry accessory, it is equivalent to the Zymed Easi-View Telemetry System (K001308). The main dif… | 2002 |
| * | K001308 | Modification to Zymed Telemetry System, Model EasiviewSummary page 3…ecompanion Nurse Station/Carecompanion Patient Station (K020584). With respect to the pulse oximetry accessory, it is equivalent to the Zymed Easi-View Telemetry System (K001308). The main difference from the predicate devices and platforms is that Telecare D.R. is a software component to the predicate de… | 2000 |
| † | K884216 | 506 Non-Invasive Vital Signs Monitor | 1989 |
| † | K982481 | A&D Medical UA-767PC Digital Blood Pressure Monitor | 1998 |
| † | K013489 | KP + LFM | 2001 |
| † | K000582 | Freestyle Blood Glucose Monitoring System, Cat NO 11001 | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073710 | Intouch Remote Presence Robotic System, Model RP-7 | 2008 | 2 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K073710 (Intouch Technologies, 2008) has gone furthest, with 2 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 Telecare®D.R. is intended to be used in conjunction with 510(k) certified devices that upon prescription by an authorized healthcare provider for patients provides a means of receiving and storing audio, video, and patient biometric data including vital signs information received over standard phone lines or high speed connection between patients, typically at home, and health professionals at the health care provider's site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033133: Telecare D.R. Server Software System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033133
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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