Erika, Inc.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Erika, Inc.” (first 1976, latest 1985), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | 13 | 13 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 8 | 8 |
| FHS | Dialyzer, Single Coil | 6 | 6 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 5 | 5 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 2 | 2 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 2 | 2 |
| FJG | Dialyzer, Parallel Flow | 1 | 1 |
| FKX | System, Peritoneal, Automatic Delivery | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Erika, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853134 | NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 | FRN | 1985-11-06 | 103 |
| K852310 | NATURALYTE BICARBONATE CONCENTRATE-DRY PACK | FKQ | 1985-07-26 | 58 |
| K852309 | ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 | FJK | 1985-07-26 | 58 |
| K850866 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L | KDI | 1985-04-03 | 33 |
| K850865 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- | FJI | 1985-04-03 | 33 |
| K850655 | TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 | FJI | 1985-03-07 | 16 |
| K850654 | TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID | FJI | 1985-03-07 | 16 |
| K842436 | ERIKA NEGATIVE PRESS. ARTERIAL BLOOD | KOC | 1984-07-13 | 23 |
| K831176 | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY | KOC | 1984-06-22 | 438 |
| K831175 | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY | KOC | 1984-06-22 | 438 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Erika, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Erika, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Erika, Inc.?
FDA lists 43 510(k) clearances under the applicant name “Erika, Inc.” (first 1976, latest 1985), across 13 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Erika, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Erika, Inc. is 50 days.
Which FDA product codes appear under Erika, Inc.?
The most frequent FDA product codes under this applicant name are KOC (Accessories, Blood Circuit, Hemodialysis, 13); FJI (Dialyzer, Capillary, Hollow Fiber, 8); FHS (Dialyzer, Single Coil, 6).
Next steps
- See all 43 Erika, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KOC, Erika, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.