NIKKISO CO., LTD.
NIKKISO CO., LTD. appears in FDA public data with 0 recalls, 11 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 15, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | May 15, 2025 |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Ser | May 15, 2025 |
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Ser | May 15, 2025 |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | July 28, 2023 |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Se | June 16, 2023 |
| K152938 | DBB-06 Hemodialysis Delivery System | March 18, 2016 |
| K091978 | DBB-06 HEMODIALYSIS DELIVERY SYSTEM | March 25, 2010 |
| K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P | March 30, 2009 |
| K061519 | MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM | September 28, 2007 |
| K953996 | NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS | March 19, 1997 |
| K803068 | NIKKISO ND-14 PARALLEL FLOW DIALYZER | March 4, 1981 |