510(k) · Cleared
ClearedRemote Care Management Systems (RCMS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bl Healthcare, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jun 8, 2005 as substantially equivalent to K023749 (Philips Medical Systems, 2002) and 5 other predicates after a 5-day review. Its family tree reaches back 7 generations to 1987. 21 later devices descend from it.
- Decided
- Jun 8, 2005
- Review
- 5 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K864318 (1987). 19 ancestors in all, the oldest K790130 (1979). 21 later devices descend from it, 9 citing it directly.
- Root · 7 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 6 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 5 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 4 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 3 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 2 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 1 generation backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- This deviceK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK071564 Motiva Monitor Device Connectivity, Model# 453564036921Philips Medical Systems · 2007
- Descendant · cites it directly · 5 of its ownK052608 Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK091579 Foresee HomeNotal Vision, Ltd. · 2009
- Descendant · 3 generations on · 3 of its ownK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K071564Motiva Monitor Device Connectivity, Model# 453564036921Philips Medical Systems · 2007 · cites it directly5descendants
- 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 · cites it directly4descendants
- K091579Foresee HomeNotal Vision, Ltd. · 2009 · 2 generations on4descendants
- K121738Myvisiontrack (TM)Vital Art and Science Incorporated · 2013 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −6 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −5 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −4 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −3 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −2 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −1 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| 0 (this device) | K051470 | Remote Care Management Systems (RCMS) | Bl Healthcare, Inc. | 2005 | — |
| +1 | K071564 | Motiva Monitor Device Connectivity, Model# 453564036921 | Philips Medical Systems | 2007 | — |
| +1 | K052608 | Telephone Based BL Healthcare Remote Care Management System (RCMS) | Bl Healthcare, Inc. | 2006 | — |
| +1 | K093379 | TCX-I-DV Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +2 | K091579 | Foresee Home | Notal Vision, Ltd. | 2009 | — |
| +3 | K121738 | Myvisiontrack (TM) | Vital Art and Science Incorporated | 2013 | — |
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 |
|---|---|---|
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B)Summary page 2…The BL Healthcare Remote Care Management system is substantially equivalent in functionality to the following predicate device(s): M3810a Philips Telemonitoring system, K023749 Carematix Wellness system, K031840 Carematix Wellness system, K040966 AvidCare Series 100 Telemanagement System, K011779 AvidCare… | 2002 |
| * | K031840 | Carematix Wellness SystemSummary page 2…ement system is substantially equivalent in functionality to the following predicate device(s): M3810a Philips Telemonitoring system, K023749 Carematix Wellness system, K031840 Carematix Wellness system, K040966 AvidCare Series 100 Telemanagement System, K011779 AvidCare Corporation Home Health Monitoring… | 2003 |
| * | K040966 | Modification to Carematix Wellness SystemSummary page 2…alent in functionality to the following predicate device(s): M3810a Philips Telemonitoring system, K023749 Carematix Wellness system, K031840 Carematix Wellness system, K040966 AvidCare Series 100 Telemanagement System, K011779 AvidCare Corporation Home Health Monitoring System, K010029 Aviva Systems, K98… | 2004 |
| * | K011779 | Avidcare Series 100 Telemanagement SystemSummary page 2…evice(s): M3810a Philips Telemonitoring system, K023749 Carematix Wellness system, K031840 Carematix Wellness system, K040966 AvidCare Series 100 Telemanagement System, K011779 AvidCare Corporation Home Health Monitoring System, K010029 Aviva Systems, K981533 Submission Device Description: BL Healthcare… | 2001 |
| * | K010029 | Home Health Monitoring SystemSummary page 2…ematix Wellness system, K031840 Carematix Wellness system, K040966 AvidCare Series 100 Telemanagement System, K011779 AvidCare Corporation Home Health Monitoring System, K010029 Aviva Systems, K981533 Submission Device Description: BL Healthcare Remote Care Management system serves as the communication l… | 2001 |
| * | K981533 | Aviva Systems Model Numbers 1010, 2020Summary page 2…K031840 Carematix Wellness system, K040966 AvidCare Series 100 Telemanagement System, K011779 AvidCare Corporation Home Health Monitoring System, K010029 Aviva Systems, K981533 Submission Device Description: BL Healthcare Remote Care Management system serves as the communication link between FDA approve… | 1998 |
What descends from it? (21)
See all 219 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071564 | Motiva Monitor Device Connectivity, Model# 453564036921 | 2007 | 5 |
| K052608 | Telephone Based BL Healthcare Remote Care Management System (RCMS) | 2006 | 5 |
| K093379 | TCX-I-DV Remote Care Management System | 2010 | 4 |
| K073710 | Intouch Remote Presence Robotic System, Model RP-7 | 2008 | 2 |
| K062662 | Telemedicine System Model VMS-01 | 2006 | 2 |
| K062127 | MEDIC4ALL Telemedicine System, Model VMS-01 (Nibp) | 2006 | 2 |
| K061502 | MEDIC4ALL Telemedicine System VMS-01 | 2006 | 2 |
| K101078 | BL Healthcare Remote Care Management System | 2010 | 1 |
| K083046 | Fora Telehealth System | 2009 | 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 18 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K071564 (Philips Medical Systems, 2007) has gone furthest, with 5 descendants of its own.
- 9 other devices also cite its predicate K023749.
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.
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 BL Healthcare Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, blood glucose monitor, and weight scale upon the prescription of a licensed physician or healthcare provider. The BL Healthcare Remote Care Management system serves as the communication link between the compatible devices and the server software at a compatible healthcare facility. The…
Read the full statement (177 words)
The BL Healthcare Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, blood glucose monitor, and weight scale upon the prescription of a licensed physician or healthcare provider. The BL Healthcare Remote Care Management system serves as the communication link between the compatible devices and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center.
The purpose of the system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
This system is installed by or with support from trained professionals.
This device is not intended to provide time sensitive data or alarms. This system may not be used as a substitute for direct medical intervention or emergency care.
Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051470: Remote Care Management Systems (RCMS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051470
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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