Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Erika, Inc. — Predicate Candidate Screening

43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

50 daysmedian FDA review time
103 days90th percentile
43clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8Erika, Inc.1985-11-061030
K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACKErika, Inc.1985-07-26580
K852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1Erika, Inc.1985-07-26580
K850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-Erika, Inc.1985-04-03330
K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LErika, Inc.1985-04-03330
K850655TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2Erika, Inc.1985-03-07160
K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KIDErika, Inc.1985-03-07160
K842436ERIKA NEGATIVE PRESS. ARTERIAL BLOODErika, Inc.1984-07-13230
K831175FILTRYZER HOLLOW FIBER ARTIF. KIDNEYErika, Inc.1984-06-224380
K831176FILTRYZER HOLLOW FIBER ARTIF. KIDNEYErika, Inc.1984-06-224380
K831173TORAY INDUSTRIES FILTRYZER HOLLOW FIBERErika, Inc.1984-06-224380
K831174FILTRYZER HOLLOW FIBER ARTIFICIAL KID-Erika, Inc.1984-06-224380
K840859MAKS CENTRAL DELIVERY SYS-11-200 ETCErika, Inc.1984-05-22880
K833906NEGATIVE PRESSURE VENOUS BLOOD LINEErika, Inc.1984-01-03500
K833905NEGATIVE PRESSURE ARTERIAL BLOODErika, Inc.1984-01-03500
K833252ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OFErika, Inc.1983-12-14850
K830326NEGATIVE PRESSURE ARTERIAL BLOOD LINEErika, Inc.1983-02-28270
K823115NATURALYTE BICARBONATE DIALYSATE 4400Erika, Inc.1982-12-03430
K822796NEGATIVE PRESSURE ARTERIAL BLOOD LINEErika, Inc.1982-10-18320
K822485HPF 100,200,300 CAPILLARY FLOW DIALYZErika, Inc.1982-08-30130
K822225ERIKA NEGAT. PRESSURE ARTER. BLOOD LINEErika, Inc.1982-08-16200
K822226ERIKA NEGATIVE PRESSURE VENOUS BLOOD LINErika, Inc.1982-08-16200
K821587ERIKA HPF 50 DIALYZERErika, Inc.1982-06-25240
K821690ERIKA HPF 100,200,300 DIALYZERErika, Inc.1982-06-22140
K821304CENTRALYTE BICARBONATE CONCENTRATEErika, Inc.1982-05-18140
K820179ERIKA CAPD PREP KIT #30-9501-5Erika, Inc.1982-02-19280
K812811MICROCOIL 80 DIALYZERErika, Inc.1981-12-03580
K811974MICROCOIL 150 DIALYZERErika, Inc.1981-09-16650
K810925NATURALYTE BICARBONATE DIALYSATE CONCEN.Erika, Inc.1981-04-23170
K810824ERIKA HEPARIN INFUSION ADAPTORErika, Inc.1981-04-17240
K810823ERIKA EXTENSION SETSErika, Inc.1981-04-17240
K800723MICRO-COIL 100 COIL DIALYZERErika, Inc.1980-05-14430
K792054ERIKA NEGATIVE PRESSURE VENOUS BL SETSErika, Inc.1979-12-06520
K792053ERIKA NEGATIVE PRESSURE ARTERILA BLOODErika, Inc.1979-12-06520
K791320ERIKA HPF 100Erika, Inc.1979-09-24740
K791322ERIKA HPF 300Erika, Inc.1979-09-24740
K791321ERIKA HPF 200Erika, Inc.1979-09-24740
K781966DIALYZER, MAGNIFLO 100 PARALLEL PLATEErika, Inc.1979-02-21890
K771349MODIFICATION TO KIDNEY DIALYZERErika, Inc.1977-08-02120
K770171ERIKA I.V. ADMINISTRATION SETErika, Inc.1977-03-30630
K770382NEEDLE, FISTULA, ERIKAErika, Inc.1977-03-0880
K760702ERI-FLO 900 DIALYZERErika, Inc.1976-11-19580
K760374DIALYZER (MODEL 1850)Erika, Inc.1976-10-27830

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda