510(k) · Cleared
ClearedRemote Presence System
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 May 24, 2012 as substantially equivalent to K073710 (Intouch Technologies, 2008) after a 62-day review. Its family tree reaches back 9 generations to 1987. 1 later device descends from it.
- Decided
- May 24, 2012
- Review
- 62 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K864318 (1987). 28 ancestors in all, the oldest K790130 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations between
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 1 generation backK073710 Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies · 2008
- This deviceK120895 Remote Presence SystemIntouch Health, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK123229 Remote Presence System, Model RP-VitaIntouch Health, Inc. · 2012
Show all 9 generations
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 7 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 6 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 5 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 4 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 1 generation backK073710 Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies · 2008
- This deviceK120895 Remote Presence SystemIntouch Health, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K123229Remote Presence System, Model RP-VitaIntouch Health, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −8 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −7 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −6 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −5 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −4 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −3 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −2 | K051470 | Remote Care Management Systems (RCMS) | Bl Healthcare, Inc. | 2005 | — |
| −1 | K073710 | Intouch Remote Presence Robotic System, Model RP-7 | Intouch Technologies | 2008 | — |
| 0 (this device) | K120895 | Remote Presence System | Intouch Health, Inc. | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K073710 | Intouch Remote Presence Robotic System, Model RP-7Summary page 1…F.R. § 870.2910, Product Code ORS; Class 11 Legally Marketed Predicate Device: InTouch Remote Presence Robotic System, Model RP-7; K073710; April 11, 2008 Device Description and Technological Characteristics: The Remote Presence System is a telecommunications platfo… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123229 | Remote Presence System, Model RP-Vita | 2012 | 0 |
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 28 ancestors have a recall of any class.
- Of its descendants, K123229 (Intouch Health, Inc., 2012) has gone furthest, with 0 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. 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 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 may also be used in conjunction with 510(k)-cleared devices that transmit patient biometric data including vital signs information. The Remote Presence System transmits and receives information over a high speed connection between patients, health professionals…
Read the full statement (121 words)
The Remote Presence System 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 may also be used in conjunction with 510(k)-cleared devices that transmit patient biometric data including vital signs information. The Remote Presence System transmits and receives information over a high speed connection between patients, health professionals and critical transport teams. The Remote Presence System 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/K120895 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120895: Remote Presence System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120895
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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