510(k) · Cleared
ClearedTCX-I 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 Dec 21, 2011 as substantially equivalent to K101078 (Bl Healthcare, Inc., 2010) after a 26-day review. Its family tree reaches back 11 generations to 1987.
- Decided
- Dec 21, 2011
- Review
- 26 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K864318 (1987). 40 ancestors in all, the oldest K790130 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations between
- 3 generations backK052608 Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
- 2 generations backK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- 1 generation backK101078 BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010
- This deviceK113493 TCX-I Remote Care Management SystemBl Healthcare, Inc. · 2011
Show all 11 generations
- Root · 11 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 10 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 9 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 8 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 7 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 6 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 5 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 4 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 3 generations backK052608 Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
- 2 generations backK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- 1 generation backK101078 BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010
- This deviceK113493 TCX-I Remote Care Management SystemBl Healthcare, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −10 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −9 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −8 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −7 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −6 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −5 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −4 | K051470 | Remote Care Management Systems (RCMS) | Bl Healthcare, Inc. | 2005 | — |
| −3 | K052608 | Telephone Based BL Healthcare Remote Care Management System (RCMS) | Bl Healthcare, Inc. | 2006 | — |
| −2 | K093379 | TCX-I-DV Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| −1 | K101078 | BL Healthcare Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K101078 | BL Healthcare Remote Care Management SystemSummary page 1…elemedicine systems Classification Product Codes: DRG, DXN, NBW, LFR, BZH, OQA, OQO, FIL, GJS Legally Marketed Predicate Device(s): TCx-l Remote Care Management System (K101078) Submission Device Description: TCx-I Remote Care Management system collects and transmits measurement information such as weig… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 40 ancestors have a recall of any class.
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. 2011, 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-I Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose and other devices 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.…
Read the full statement (111 words)
The purpose of the TCx-I Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose and other devices 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 judgement by an experienced medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113493: TCX-I Remote Care Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113493
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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