Company ยท US
Erika, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1985. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | 13 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 8 |
| FHS | Dialyzer, Single Coil | 6 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 5 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 2 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 2 |
| FJG | Dialyzer, Parallel Flow | 1 |
| FKX | System, Peritoneal, Automatic Delivery | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| FRN | Pump, Infusion | 1 |
| KDC | Instrument, Surgical, Disposable | 1 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 1985 | K853134 | NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 Erika, Inc. | FRN |
| Jul 26, 1985 | K852310 | NATURALYTE BICARBONATE CONCENTRATE-DRY PACK Erika, Inc. | FKQ |
| Jul 26, 1985 | K852309 | ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 Erika, Inc. | FJK |
| Apr 3, 1985 | K850866 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L Erika, Inc. | KDI |
| Apr 3, 1985 | K850865 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- Erika, Inc. | FJI |
| Mar 7, 1985 | K850655 | TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 Erika, Inc. | FJI |
| Mar 7, 1985 | K850654 | TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID Erika, Inc. | FJI |
| Jul 13, 1984 | K842436 | ERIKA NEGATIVE PRESS. ARTERIAL BLOOD Erika, Inc. | KOC |
| Jun 22, 1984 | K831176 | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY Erika, Inc. | KOC |
| Jun 22, 1984 | K831175 | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY Erika, Inc. | KOC |
| Jun 22, 1984 | K831174 | FILTRYZER HOLLOW FIBER ARTIFICIAL KID- Erika, Inc. | KOC |
| Jun 22, 1984 | K831173 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER Erika, Inc. | KOC |
| May 22, 1984 | K840859 | MAKS CENTRAL DELIVERY SYS-11-200 ETC Erika, Inc. | KOC |
| Jan 3, 1984 | K833906 | NEGATIVE PRESSURE VENOUS BLOOD LINE Erika, Inc. | KOC |
| Jan 3, 1984 | K833905 | NEGATIVE PRESSURE ARTERIAL BLOOD Erika, Inc. | KOC |
| Dec 14, 1983 | K833252 | ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF Erika, Inc. | KOC |
| Feb 28, 1983 | K830326 | NEGATIVE PRESSURE ARTERIAL BLOOD LINE Erika, Inc. | KDC |
| Dec 3, 1982 | K823115 | NATURALYTE BICARBONATE DIALYSATE 4400 Erika, Inc. | KRO |
| Oct 18, 1982 | K822796 | NEGATIVE PRESSURE ARTERIAL BLOOD LINE Erika, Inc. | KOC |
| Aug 30, 1982 | K822485 | HPF 100,200,300 CAPILLARY FLOW DIALYZ Erika, Inc. | FKQ |
| Aug 16, 1982 | K822226 | ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN Erika, Inc. | KOC |
| Aug 16, 1982 | K822225 | ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE Erika, Inc. | KOC |
| Jun 25, 1982 | K821587 | ERIKA HPF 50 DIALYZER Erika, Inc. | FJI |
| Jun 22, 1982 | K821690 | ERIKA HPF 100,200,300 DIALYZER Erika, Inc. | FJI |
| May 18, 1982 | K821304 | CENTRALYTE BICARBONATE CONCENTRATE Erika, Inc. | KPO |
| Feb 19, 1982 | K820179 | ERIKA CAPD PREP KIT #30-9501-5 Erika, Inc. | FKX |
| Dec 3, 1981 | K812811 | MICROCOIL 80 DIALYZER Erika, Inc. | FHS |
| Sep 16, 1981 | K811974 | MICROCOIL 150 DIALYZER Erika, Inc. | FHS |
| Apr 23, 1981 | K810925 | NATURALYTE BICARBONATE DIALYSATE CONCEN. Erika, Inc. | KPO |
| Apr 17, 1981 | K810824 | ERIKA HEPARIN INFUSION ADAPTOR Erika, Inc. | FJK |
| Apr 17, 1981 | K810823 | ERIKA EXTENSION SETS Erika, Inc. | FJK |
| May 14, 1980 | K800723 | MICRO-COIL 100 COIL DIALYZER Erika, Inc. | FHS |
| Dec 6, 1979 | K792054 | ERIKA NEGATIVE PRESSURE VENOUS BL SETS Erika, Inc. | FJK |
| Dec 6, 1979 | K792053 | ERIKA NEGATIVE PRESSURE ARTERILA BLOOD Erika, Inc. | FJK |
| Sep 24, 1979 | K791322 | ERIKA HPF 300 Erika, Inc. | FJI |
| Sep 24, 1979 | K791321 | ERIKA HPF 200 Erika, Inc. | FJI |
| Sep 24, 1979 | K791320 | ERIKA HPF 100 Erika, Inc. | FJI |
| Feb 21, 1979 | K781966 | DIALYZER, MAGNIFLO 100 PARALLEL PLATE Erika, Inc. | FJG |
| Aug 2, 1977 | K771349 | MODIFICATION TO KIDNEY DIALYZER Erika, Inc. | FHS |
| Mar 30, 1977 | K770171 | ERIKA I.V. ADMINISTRATION SET Erika, Inc. | FPA |
| Mar 8, 1977 | K770382 | NEEDLE, FISTULA, ERIKA Erika, Inc. | KOC |
| Nov 19, 1976 | K760702 | ERI-FLO 900 DIALYZER Erika, Inc. | FHS |
| Oct 27, 1976 | K760374 | DIALYZER (MODEL 1850) Erika, Inc. | FHS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||