FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
K Number: K112628
·
Decision Sep 28, 2012
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
76
Applicant Total
34
Review Days
385
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
- K Number
- K112628
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nipro Medical Corporation
- Date Received
- September 9, 2011
- Decision Date
- September 28, 2012
- Product Code
- FJK
- 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 |
|---|---|---|---|
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FJK), ordered by most recent decision date.
NovaLine Tubing Set for Hemodialysis (BL 124)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VITAL Tubing Sets for Hemodialysis
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Moda-flx Hemodialysis System Cartridge (102121-001 )
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CombiSet Hemodialysis Blood Tubing Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tablo Cartridge
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Nipro Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K253047 | PRESSONE | Mar 24, 2026 | Substantially Equivalent |
| K260533 | ELISIO-H | Mar 19, 2026 | Substantially Equivalent |
| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | May 25, 2023 | Substantially Equivalent |
| K212677 | aboNT SYRINGE | Apr 15, 2022 | Substantially Equivalent |
| K190037 | Cronus HP PTA Balloon Catheter | Oct 24, 2019 | Substantially Equivalent |
| K191359 | Nipro Syringe | Oct 9, 2019 | Substantially Equivalent |
| K182940 | Surdial DX Hemodialysis System | Jul 19, 2019 | Substantially Equivalent |
| K173029 | Nipro Syringe | Mar 30, 2018 | Substantially Equivalent |
| K161681 | Nipro SafeTouch IV Catheter | Mar 8, 2017 | Substantially Equivalent |
| K160444 | FB-U Hemodialyzer | Feb 8, 2017 | Substantially Equivalent |