Amuchina Intl., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Amuchina Intl., Inc.” (first 1986, latest 2000), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 209 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 |
|---|---|---|---|
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 1 | 1 |
| FKX | System, Peritoneal, Automatic Delivery | 1 | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 | 1 |
| LIF | Dialyzer Reprocessing System | 1 | 1 |
| LRJ | Disinfectant, Medical Devices | 1 | 1 |
Review panels
Most recent Amuchina Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992016 | AMUKIN D | LIF | 2000-01-10 | 209 |
| K952302 | AMUCHINA | LRJ | 1995-07-26 | 71 |
| K871583 | MODIFIED LABELING FOR AMUKIN-50% | KDJ | 1987-07-09 | 77 |
| K862928 | AMUKIN-50% FOR CAPD Y-SET | FKX | 1987-03-09 | 220 |
| K852359 | AMUCHINA/DIALYZER DISINFECTANT | FKQ | 1986-05-13 | 343 |
Recalls
openFDA lists no recalls under a recalling firm named Amuchina Intl., 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 Amuchina Intl., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Amuchina Intl., Inc.” (first 1986, latest 2000), across 5 product codes in 2 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 Amuchina Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amuchina Intl., Inc. is 209 days.
Which FDA product codes appear under Amuchina Intl., Inc.?
The most frequent FDA product codes under this applicant name are FKQ (System, Dialysate Delivery, Central Multiple Patient, 1); FKX (System, Peritoneal, Automatic Delivery, 1); KDJ (Set, Administration, For Peritoneal Dialysis, Disposable, 1).
Next steps
- See all 5 Amuchina Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FKQ, Amuchina Intl., 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.