510(k) · Cleared
ClearedBL Healthcare Remote Care Management System
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 May 10, 2010 as substantially equivalent to K052608 (Bl Healthcare, Inc., 2006) and 4 other predicates after a 21-day review. Its family tree reaches back 10 generations to 1987. 1 later device descends from it.
- Decided
- May 10, 2010
- Review
- 21 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K864318 (1987). 39 ancestors in all, the oldest K790130 (1979). 1 later device descends from it, 1 citing it directly.
- 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 backK052608 Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
- 1 generation backK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- This deviceK101078 BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK113493 TCX-I Remote Care Management SystemBl Healthcare, Inc. · 2011
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 backK052608 Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
- 1 generation backK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- This deviceK101078 BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K113493TCX-I Remote Care Management SystemBl Healthcare, Inc. · 2011 · cites it directly0descendants
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 | 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 | — |
| 0 (this device) | K101078 | BL Healthcare Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +1 | K113493 | TCX-I Remote Care Management System | Bl Healthcare, Inc. | 2011 | — |
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 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (5)
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 |
|---|---|---|---|
| * | K052608 | Telephone Based BL Healthcare Remote Care Management System (RCMS) | 2006 |
| * | K051470 | Remote Care Management Systems (RCMS)Summary page 1…ystem, eHealth device 3. Legally Marketed Predicate Device(s): Telephone Based TCx-I Remote Care Management system (RCMS) (K05260B) TCx-l Remote Care Management system (K051470) TCx-I Remote Care Management System (K093379) RNK Telephonic Stethoscope Model TR-1 (K034046) Carematix Wellness System (K073038… | 2005 |
| * | K093379 | TCX-I-DV Remote Care Management SystemSummary page 1…dicate Device(s): Telephone Based TCx-I Remote Care Management system (RCMS) (K05260B) TCx-l Remote Care Management system (K051470) TCx-I Remote Care Management System (K093379) RNK Telephonic Stethoscope Model TR-1 (K034046) Carematix Wellness System (K073038) 4. Device Description: TCx-l Remote Care M… | 2010 |
| * | K034046 | RNK Telephonic Stethoscope, Model TR-1Summary page 1…are Management system (RCMS) (K05260B) TCx-l Remote Care Management system (K051470) TCx-I Remote Care Management System (K093379) RNK Telephonic Stethoscope Model TR-1 (K034046) Carematix Wellness System (K073038) 4. Device Description: TCx-l Remote Care Management system collects and transmits measurem… | 2004 |
| * | K073038 | Carematix Wellness System, Model CWS-5000.1-BSummary page 1…B) TCx-l Remote Care Management system (K051470) TCx-I Remote Care Management System (K093379) RNK Telephonic Stethoscope Model TR-1 (K034046) Carematix Wellness System (K073038) 4. Device Description: TCx-l Remote Care Management system collects and transmits measurement information such as weight, bloo… | 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 |
|---|---|---|---|
| K113493 | TCX-I Remote Care Management System | 2011 | 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 23 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 39 ancestors have a recall of any class.
- Of its descendants, K113493 (Bl Healthcare, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052608.
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. 2010, 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 purpose of the TCx-l Remote Care Management 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. The system supports videoconferencing, multimedia education and messages. This system is installed by or with support from trained professionals. This device is not…
Read the full statement (108 words)
The purpose of the TCx-l Remote Care Management 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. The system supports videoconferencing, multimedia education and messages.
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 judgment by an experienced medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101078 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101078: BL Healthcare Remote Care Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101078
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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