FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Surdial DX Hemodialysis System
K Number: K182940
·
Decision Jul 19, 2019
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
34
Review Days
269
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Basic Information
- Device Name
- Surdial DX Hemodialysis System
- K Number
- K182940
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nipro Medical Corporation
- Date Received
- October 23, 2018
- Decision Date
- July 19, 2019
- Product Code
- KDI
- 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 |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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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 |
| 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 |
| K151141 | Cronus HP - High Pressure Peripheral Balloon Catheter | Jan 14, 2016 | Substantially Equivalent |