Company ยท JP
NIKKISO CO., LTD.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2025. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2025 | K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CD NIKKISO CO., LTD., JP | KOC |
| May 15, 2025 | K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL NIKKISO CO., LTD., JP | KOC |
| May 15, 2025 | K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) NIKKISO CO., LTD., JP | KDI |
| Jul 28, 2023 | K231589 | Blood Tubing Lines for Hemodialysis AV06C-E NIKKISO CO., LTD., JP | KOC |
| Jun 16, 2023 | K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series NIKKISO CO., LTD., JP | KOC |
| Mar 18, 2016 | K152938 | DBB-06 Hemodialysis Delivery System NIKKISO CO., LTD., JP | KDI |
| Mar 25, 2010 | K091978 | DBB-06 HEMODIALYSIS DELIVERY SYSTEM NIKKISO CO., LTD., JP | KDI |
| Mar 30, 2009 | K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P NIKKISO CO., LTD., JP | KOC |
| Sep 28, 2007 | K061519 | MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM NIKKISO CO., LTD., JP | KDI |
| Mar 19, 1997 | K953996 | NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS NIKKISO CO., LTD. | KDI |
| Mar 4, 1981 | K803068 | NIKKISO ND-14 PARALLEL FLOW DIALYZER NIKKISO CO., LTD. | FJG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||