Tcx-I-Dv Remote Care Management System
FDA 510(k) K093379 · Bl Healthcare, Inc.
510(k) numberK093379
Submission
- Device name
- Tcx-I-Dv Remote Care Management System
- Applicant
- Bl Healthcare, Inc.
Foxboro, MA, US - Received
- October 29, 2009
- Decision date
- February 9, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K113493 | Tcx-I Remote Care Management SystemDRG · Special | 12/21/2011SE |
| K101078 | BL Healthcare Remote Care Management SystemDRG · Special | 05/10/2010SE |
| K052608 | Telephone Based BL Healthcare Remote Care Management System (RCMS)DRG · Traditional | 02/01/2006SE |
| K051470 | Remote Care Management Systems (RCMS)DRG · Traditional | 06/08/2005SE |
Questions and answers
When was Tcx-I-Dv Remote Care Management System cleared by the FDA?
Tcx-I-Dv Remote Care Management System (K093379) received a 510(k) decision of Substantially Equivalent on February 9, 2010, 103 days after the submission was received.
What is the product code of K093379?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.