FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HemoCare Bicarbonate Concentrate Set (BCS)
K Number: K240920
·
Decision Jul 12, 2024
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
122
Applicant Total
13
Review Days
99
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Basic Information
- Device Name
- HemoCare Bicarbonate Concentrate Set (BCS)
- K Number
- K240920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deka Research and Development
- Date Received
- April 4, 2024
- Decision Date
- July 12, 2024
- Product Code
- KPO
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPO), ordered by most recent decision date.
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)
FDA 510(k)
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pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
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FDA Class 2
·Gastroenterology, Urology
NxStage PureFlow Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Deka Research and Development
| K Number | Device Name | ||
|---|---|---|---|
| K261672 | twiist Automated Insulin Delivery (AID) System | Jun 17, 2026 | Substantially Equivalent |
| K261530 | iiSure Infusion Set | Jun 3, 2026 | Substantially Equivalent |
| K243841 | Sparta Infusion Set for Insulin | Aug 1, 2025 | Substantially Equivalent |
| K233557 | HemoCare Hemodialysis System | Jul 12, 2024 | Substantially Equivalent |
| K240256 | Remunity System | Jun 12, 2024 | Substantially Equivalent |
| K241178 | DEKA ACE Pump System | May 24, 2024 | Substantially Equivalent |
| K234055 | DEKA Loop | Mar 13, 2024 | Substantially Equivalent |
| K233952 | DEKA ACE Pump System | Mar 13, 2024 | Substantially Equivalent |
| K232316 | DEKA Infusion System, DEKA Administration Set | Mar 1, 2024 | Substantially Equivalent |
| K213536 | DEKA ACE Pump System | Jul 25, 2023 | Substantially Equivalent |