Amicon, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Amicon, Inc.” (first 1976, latest 1993), across 8 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 |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 8 | 8 |
| JJH | Clinical Sample Concentrator | 6 | 6 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 | 1 |
| JJP | Electrode, Ion Selective (Non-Specified) | 1 | 1 |
| JQQ | Dialyzer | 1 | 1 |
| JRL | Unit, Filter, Membrane | 1 | 1 |
| KJF | System, Suspension, Cell Culture | 1 | 1 |
| KPF | System, Dialysate Delivery, Semi-Automatic, Peritoneal | 1 | 1 |
Review panels
Most recent Amicon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K930168 | CENTRICON -50 CONCENTRATOR | JJH | 1993-08-05 | 204 |
| K902837 | AMICON DIAFILTER 30 HEMOCONCENTRATOR | KDI | 1990-11-01 | 126 |
| K901286 | AMICON HEMOCONCENTRATOR SET | KDI | 1990-05-18 | 59 |
| K900280 | CENTRIPREP 100 | JJP | 1990-02-16 | 29 |
| K895405 | AMICON MINIFILTER PLUS HEMOFILTER | KDI | 1990-01-11 | 126 |
| K893733 | CENTRICON CONCENTRATOR | JJH | 1989-07-20 | 64 |
| K892645 | AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY | KJF | 1989-06-13 | 62 |
| K875121 | AMICON EQUALINE FLUID BALANCE SYSTEM | KPF | 1988-02-19 | 66 |
| K870690 | CENTRIPREP CONCENTRATOR | JJH | 1987-03-19 | 28 |
| K863823 | AMICON DIAFILTER HEMOFILTER | KDI | 1986-11-06 | 37 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Amicon, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Amicon, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Amicon, Inc.” (first 1976, latest 1993), across 8 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 Amicon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amicon, Inc. is 50 days.
Which FDA product codes appear under Amicon, Inc.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 8); JJH (Clinical Sample Concentrator, 6); DHX (System, Test, Carcinoembryonic Antigen, 1).
Next steps
- See all 20 Amicon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Amicon, 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.