510(k) · Cleared
ClearedTelephone Based BL Healthcare Remote Care Management System (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 Feb 1, 2006 as substantially equivalent to K051470 (Bl Healthcare, Inc., 2005) and 3 other predicates after a 132-day review. Its family tree reaches back 8 generations to 1987. 5 later devices descend from it.
- Decided
- Feb 1, 2006
- Review
- 132 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K864318 (1987). 26 ancestors in all, the oldest K790130 (1979). 5 later devices descend from it, 2 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 deviceK052608 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 · 1 of its ownK131739 Nxstage Connected Health SystemNxstage Medical, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK101078 BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK181991 NxStage Connected Health SystemNxstage Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK113493 TCX-I Remote Care Management SystemBl Healthcare, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010 · cites it directly4descendants
- K131739Nxstage Connected Health SystemNxstage Medical, Inc. · 2013 · 2 generations on1descendant
- K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010 · cites it directly1descendant
- K181991NxStage Connected Health SystemNxstage Medical, Inc. · 2018 · 3 generations on0descendants
- K113493TCX-I Remote Care Management SystemBl Healthcare, Inc. · 2011 · 2 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) | 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 | K131739 | Nxstage Connected Health System | Nxstage Medical, Inc. | 2013 | — |
| +1 | K101078 | BL Healthcare Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +3 | K181991 | NxStage Connected Health System | Nxstage Medical, Inc. | 2018 | — |
| +2 | 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 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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? (4)
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…System Common Name: Telemedicine systems Regulation Number: 870.291 0. DRG Regulatory Status: Class LI Predicate Devices: BL Healthcare Remote Care Management Systems, K05 1470 Carematix Modified System, K040966 Zymed EasyView telemetry system (KOO 1308) Motion Media Care Station 126S Videophone (K03) 186… | 2005 |
| * | K040966 | Modification to Carematix Wellness SystemSummary page 1…tems Regulation Number: 870.291 0. DRG Regulatory Status: Class LI Predicate Devices: BL Healthcare Remote Care Management Systems, K05 1470 Carematix Modified System, K040966 Zymed EasyView telemetry system (KOO 1308) Motion Media Care Station 126S Videophone (K03) 1863) Submission Device Description… | 2004 |
| * | K001308 | Modification to Zymed Telemetry System, Model Easiview | 2000 |
| * | K031863 | Carestation 126S VideophoneSummary page 2…Fl)A 510(k) Page 1 1 ~Ko L5 fl) (K03 1863). The Carematix Modified System supports monitoring of Peak Flow and Oxygen levels, weight, blood pressure, blood glucose and spi… | 2003 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K093379 (Bl Healthcare, Inc., 2010) 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.
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 Telephone based BL Healthcare Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, blood glucose, SPO2, FEVI and PEE 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/K052608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052608: Telephone Based BL Healthcare Remote Care Management System (RCMS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052608
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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