FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
K Number: K242176
·
Decision May 15, 2025
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
181
Applicant Total
11
Review Days
295
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Basic Information
- Device Name
- BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
- K Number
- K242176
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NIKKISO CO., LTD.
- Date Received
- July 24, 2024
- Decision Date
- May 15, 2025
- Product Code
- KOC
- 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOC), ordered by most recent decision date.
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Blood Tubing Lines for Hemodialysis AV06C-E
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAREline Airless Hemodialysis Blood Tubing Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CRIT-LINE III Blood Chamber II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by NIKKISO CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | May 15, 2025 | Substantially Equivalent |
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU | May 15, 2025 | Substantially Equivalent |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | Jul 28, 2023 | Substantially Equivalent |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | Jun 16, 2023 | Substantially Equivalent |
| K152938 | DBB-06 Hemodialysis Delivery System | Mar 18, 2016 | Substantially Equivalent |
| K091978 | DBB-06 HEMODIALYSIS DELIVERY SYSTEM | Mar 25, 2010 | Substantially Equivalent |
| K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P | Mar 30, 2009 | Substantially Equivalent |
| K061519 | MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM | Sep 28, 2007 | Substantially Equivalent |
| K953996 | NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS | Mar 19, 1997 | Substantially Equivalent |
| K803068 | NIKKISO ND-14 PARALLEL FLOW DIALYZER | Mar 4, 1981 | Substantially Equivalent |