510(k) · Cleared
ClearedMotiva Monitor Device Connectivity, Model# 453564036921
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Aug 31, 2007 as substantially equivalent to K051470 (Bl Healthcare, Inc., 2005) after an 85-day review. Its family tree reaches back 8 generations to 1987. 5 later devices descend from it.
- Decided
- Aug 31, 2007
- Review
- 85 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K864318 (1987). 20 ancestors in all, the oldest K790130 (1979). 5 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 6 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 5 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 4 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 3 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 2 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 1 generation backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- This deviceK071564 Motiva Monitor Device Connectivity, Model# 453564036921Philips Medical Systems · 2007
- Descendant · cites it directly · 4 of its ownK091579 Foresee HomeNotal Vision, Ltd. · 2009
- Descendant · 2 generations on · 3 of its ownK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
- Descendant · 3 generations on · 2 of its ownK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
- Descendant · 4 generations on · 1 of its ownK180895 AlleyeOculocare Medical AG · 2018
- Descendant · 5 generations on · 0 of its ownK203594 EyeCTesterNeuro-Eye Diagnostic Systems, LLC · 2022
Most influential descendants
Showing 5 of 5 · See all- K091579Foresee HomeNotal Vision, Ltd. · 2009 · cites it directly4descendants
- K121738Myvisiontrack (TM)Vital Art and Science Incorporated · 2013 · 2 generations on3descendants
- K143211myVision Track Model 005Vital Art and Science Incorporated · 2015 · 3 generations on2descendants
- K180895AlleyeOculocare Medical AG · 2018 · 4 generations on1descendant
- K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −7 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −6 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −5 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −4 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −3 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −2 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −1 | K051470 | Remote Care Management Systems (RCMS) | Bl Healthcare, Inc. | 2005 | — |
| 0 (this device) | K071564 | Motiva Monitor Device Connectivity, Model# 453564036921 | Philips Medical Systems | 2007 | — |
| +1 | K091579 | Foresee Home | Notal Vision, Ltd. | 2009 | — |
| +2 | K121738 | Myvisiontrack (TM) | Vital Art and Science Incorporated | 2013 | — |
| +3 | K143211 | myVision Track Model 005 | Vital Art and Science Incorporated | 2015 | — |
| +4 | K180895 | Alleye | Oculocare Medical AG | 2018 | — |
| +5 | K203594 | EyeCTester | Neuro-Eye Diagnostic Systems, LLC | 2022 | — |
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 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K051470 | Remote Care Management Systems (RCMS)Summary page 1…Legally Marketed Predicate Device: Sponsor Predicate Device 510(k) Number BL Healthcare, Inc. BL Management K051470 Remote Care Management System PHILIPS… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091579 | Foresee Home | 2009 | 4 |
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 20 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K091579 (Notal Vision, Ltd., 2009) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K051470.
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. 2007, 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?
Motiva is used in non-clinical settings to support effective care management of in home patients, by collecting, documenting and transmitting historical health-related patient information. The Motiva Monitor Device Connectivity is used in conjunction with Motiva's Guide Service as a communication tool enabling healthcare providers the ability to remotely educate, motivate, and communicate with their patients, in combination with the ability to…
Read the full statement (116 words)
Motiva is used in non-clinical settings to support effective care management of in home patients, by collecting, documenting and transmitting historical health-related patient information.
The Motiva Monitor Device Connectivity is used in conjunction with Motiva's Guide Service as a communication tool enabling healthcare providers the ability to remotely educate, motivate, and communicate with their patients, in combination with the ability to automatically collect in home patient parameter information derived from approved medical devices.
Motiva is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the direct supervision and oversight of an appropriate healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071564 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071564: Motiva Monitor Device Connectivity, Model# 453564036921.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071564
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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