510(k) · Cleared
ClearedTCX-I-DV Remote Care Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bl Healthcare, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Cleared on Feb 9, 2010 as substantially equivalent to K051470 (Bl Healthcare, Inc., 2005) and 3 other predicates after a 103-day review. Its family tree reaches back 9 generations to 1987. 4 later devices descend from it.
- Decided
- Feb 9, 2010
- Review
- 103 days
- Class
- Class II
- Product code
- KDI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K864318 (1987). 34 ancestors in all, the oldest K790130 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations between
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 1 generation backK052608 Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
- This deviceK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · cites it directly · 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 · 2 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
Show all 9 generations
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 7 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 6 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 5 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 4 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 3 generations backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- 2 generations backK051470 Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005
- 1 generation backK052608 Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
- This deviceK093379 TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K131739Nxstage Connected Health SystemNxstage Medical, Inc. · 2013 · cites it directly1descendant
- K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010 · cites it directly1descendant
- K181991NxStage Connected Health SystemNxstage Medical, Inc. · 2018 · 2 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 |
|---|---|---|---|---|---|
| −9 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −8 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −7 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −6 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −5 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −4 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −3 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| −2 | K051470 | Remote Care Management Systems (RCMS) | Bl Healthcare, Inc. | 2005 | — |
| −1 | K052608 | Telephone Based BL Healthcare Remote Care Management System (RCMS) | Bl Healthcare, Inc. | 2006 | — |
| 0 (this device) | K093379 | TCX-I-DV Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +1 | K131739 | Nxstage Connected Health System | Nxstage Medical, Inc. | 2013 | — |
| +1 | K101078 | BL Healthcare Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +2 | 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 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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 KDI? 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 KDI device
- #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 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…Trade Name: TCx-I-DV Remote Care Management system Common Name: Telemedicine systems Legally Marketed Predicate Device(s): BL Healthcare Remote Care Management system (K051470) Telephone Based TCx-l-DV Remote Care Management system (RCMS) (K052608) MedApps' Remote Patient Monitoring System (K062377) Exal… | 2005 |
| * | K052608 | Telephone Based BL Healthcare Remote Care Management System (RCMS)Summary page 1…icine systems Legally Marketed Predicate Device(s): BL Healthcare Remote Care Management system (K051470) Telephone Based TCx-l-DV Remote Care Management system (RCMS) (K052608) MedApps' Remote Patient Monitoring System (K062377) Exalis software 1.15 (K083158) Submission Device Description: TCx-I-DV Rem… | 2006 |
| * | K062377 | Medapps Remote Patient Monitoring, Model MA 100Summary page 1…BL Healthcare Remote Care Management system (K051470) Telephone Based TCx-l-DV Remote Care Management system (RCMS) (K052608) MedApps' Remote Patient Monitoring System (K062377) Exalis software 1.15 (K083158) Submission Device Description: TCx-I-DV Remote Care Management system collects and transmits me… | 2007 |
| * | K083158 | Exalis, Software Version 1.15Summary page 1…gement system (K051470) Telephone Based TCx-l-DV Remote Care Management system (RCMS) (K052608) MedApps' Remote Patient Monitoring System (K062377) Exalis software 1.15 (K083158) Submission Device Description: TCx-I-DV Remote Care Management system collects and transmits measurement information such as w… | 2009 |
What descends from it? (4)
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 23 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 34 ancestors have a recall of any class.
- Of its descendants, K131739 (Nxstage Medical, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K051470.
How does its category compare?
All KDI devicesKDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KDI
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDI
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDI
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDI
2,786in 2025
MAUDE reports naming product code KDI, 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 | 11 | 91 | 4 | 916 |
| 2008 | 6 | 148 | 0 | 1,042 |
| 2009 | 4 | 236 | 3 | 522 |
| 2010 | 9 | 186 | 1 | 823 |
| 2011 | 5 | 85 | 4 | 2,270 |
| 2012 | 6 | 153 | 1 | 1,765 |
| 2013 | 11 | 247 | 2 | 2,360 |
| 2014 | 8 | 164 | 3 | 6,154 |
| 2015 | 5 | 69 | 5 | 4,182 |
| 2016 | 5 | 230 | 4 | 766 |
| 2017 | 8 | 188 | 1 | 963 |
| 2018 | 2 | — | 1 | 1,716 |
| 2019 | 4 | 263 | 6 | 1,587 |
| 2020 | 9 | 266 | 0 | 1,633 |
| 2021 | 2 | — | 2 | 1,944 |
| 2022 | 7 | 259 | 17 | 2,180 |
| 2023 | 7 | 157 | 8 (8) | 2,692 |
| 2024 | 7 | 235 | 4 (2) | 2,441 |
| 2025 | 9 | 199 | 2 | 2,786 |
| 2026 | 6 | 154 | 2 | — |
What is it indicated for?
The TCx-I-DV Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, NxStage System One Hemo Dialysis system, and weight scale upon the prescription of a licensed physician or healthcare provider. The TCx-I-DV 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 (178 words)
The TCx-I-DV Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, NxStage System One Hemo Dialysis system, and weight scale upon the prescription of a licensed physician or healthcare provider. The TCx-I-DV 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 dialysis data 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/K093379 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093379: TCX-I-DV 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/K093379
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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