Medionics International, Inc.: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Medionics International, Inc.” (first 1995, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 95 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 | 1 | 57 |
| 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 |
|---|---|---|---|
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 2 | 2 |
| FKX | System, Peritoneal, Automatic Delivery | 1 | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 | 1 |
Review panels
Most recent Medionics International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130441 | FALLER STYLET | FJS | 2013-04-19 | 57 |
| K993149 | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | FJS | 2000-04-28 | 220 |
| K994218 | EASY CARE AND TUBING SETS | FKX | 2000-02-10 | 57 |
| K945567 | QC CAP | KDJ | 1995-02-07 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Medionics International, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medionics International , Ltd. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medionics International, Inc.?
FDA lists 4 510(k) clearances under the applicant name “Medionics International, Inc.” (first 1995, latest 2013), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medionics International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medionics International, Inc. is 95 days.
Which FDA product codes appear under Medionics International, Inc.?
The most frequent FDA product codes under this applicant name are FJS (Catheter, Peritoneal, Long-Term Indwelling, 2); FKX (System, Peritoneal, Automatic Delivery, 1); KDJ (Set, Administration, For Peritoneal Dialysis, Disposable, 1).
Next steps
- See all 4 Medionics International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FJS, Medionics International, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.