510(k) · Cleared
ClearedRemote Presence System, Model RP-Vita
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intouch Health, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Nov 20, 2012 as substantially equivalent to K120895 (Intouch Health, Inc., 2012) after a 36-day review. Its family tree reaches back 10 generations to 1987.
- Decided
- Nov 20, 2012
- Review
- 36 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K864318 (1987). 29 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 6 generations between
- 3 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 2 generations backK073710 Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies · 2008
- 1 generation backK120895 Remote Presence SystemIntouch Health, Inc. · 2012
- This deviceK123229 Remote Presence System, Model RP-VitaIntouch Health, Inc. · 2012
Show all 10 generations
- Root · 10 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 9 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 8 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 7 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 6 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 5 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 4 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 3 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 2 generations backK073710 Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies · 2008
- 1 generation backK120895 Remote Presence SystemIntouch Health, Inc. · 2012
- This deviceK123229 Remote Presence System, Model RP-VitaIntouch Health, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −9 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −8 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −7 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −6 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −5 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −4 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −3 | K051470 | Remote Care Management Systems (RCMS) | Bl Healthcare, Inc. | 2005 | — |
| −2 | K073710 | Intouch Remote Presence Robotic System, Model RP-7 | Intouch Technologies | 2008 | — |
| −1 | K120895 | Remote Presence System | Intouch Health, Inc. | 2012 | — |
| 0 (this device) | K123229 | Remote Presence System, Model RP-Vita | Intouch Health, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 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 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 |
|---|---|---|---|
| * | K120895 | Remote Presence SystemSummary page 1…roduct code (classification): 21 C.F.R. § 870.2910, Product Code DRG; Class 11 Legally Marketed Predicate Device: InTouch Remote Presence System, Model RP-7i; K120895; May 24, 2012. Device Description and Technological Characteristics: The Remote Presence System, Model RP-VTATM1 is… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 9 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 29 ancestors have a recall of any class.
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. 2012, this device’s year, is highlighted.
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 Remote Presence System, Model RP-VTA TM is a clinical communications tool that provides a means of transmitting, receiving, and storing real-time audio and video, and patient data. The Remote Presence System, Model RP-VITA TM may also be used in conjunction with 510(k)-cleared devices that transmit patient biometric data including vital signs information. The Remote Presence System, Model RP-VITA TM transmits and receives information over a high…
Read the full statement (129 words)
The Remote Presence System, Model RP-VTA TM is a clinical communications tool that provides a means of transmitting, receiving, and storing real-time audio and video, and patient data. The Remote Presence System, Model RP-VITA TM may also be used in conjunction with 510(k)-cleared devices that transmit patient biometric data including vital signs information. The Remote Presence System, Model RP-VITA TM transmits and receives information over a high speed connection between patients, and health professionals. The Remote Presence System, Model RP-VITAm can be used in communications for active patient monitoring in high acuity clinical environments where immediate clinical action may be required, e.g., pre-, peni-operative and post-surgical, cardiovascular, neurological. pre-natal, psychological and critical care assessments and examinations. Clinical judgment and experience are required to review and interpret the information transmitted.
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/K123229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123229: Remote Presence System, Model RP-Vita.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123229
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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