Superdimension, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Superdimension, Inc.” (first 2011, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 128 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 | 1 | 225 |
| 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
Review panels
- Radiology (2)
Most recent Superdimension, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120796 | SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER | JAK | 2012-10-26 | 225 |
| K110093 | SUPERDIMENSION MARKER DELIVERY KIT | JAK | 2011-02-11 | 30 |
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2012-06-18.
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.
- Superdimension, Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Superdimension, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Superdimension, Inc.” (first 2011, latest 2012), across 1 product code 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 Superdimension, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Superdimension, Inc. is 128 days.
Which FDA product codes appear under Superdimension, Inc.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 2).
Next steps
- See all 2 Superdimension, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Superdimension, 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.