Nitinol Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Nitinol Medical Technologies, Inc.” (first 1990, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time under this name: 157 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 |
|---|---|---|---|
| DTK | Filter, Intravascular, Cardiovascular | 7 | 7 |
Review panels
- Cardiovascular (7)
Most recent Nitinol Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970099 | SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM | DTK | 1997-04-16 | 93 |
| K963016 | SIMON NITINOL FILTER SYSTEM | DTK | 1996-11-18 | 108 |
| K963014 | SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM | DTK | 1996-11-18 | 108 |
| K944353 | SIMON NITINOL FILTER | DTK | 1995-04-28 | 241 |
| K940489 | SIMON NITINOL FILTER | DTK | 1994-08-09 | 196 |
| K912144 | SIMON NITINOL FILTER, MODIFICATION | DTK | 1991-10-17 | 157 |
| K894703 | SIMON NITINOL FILTER | DTK | 1990-04-20 | 270 |
Recalls
openFDA lists no recalls under a recalling firm named Nitinol Medical Technologies, 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 Nitinol Medical Technologies, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Nitinol Medical Technologies, Inc.” (first 1990, latest 1997), 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 Nitinol Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nitinol Medical Technologies, Inc. is 157 days.
Which FDA product codes appear under Nitinol Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are DTK (Filter, Intravascular, Cardiovascular, 7).
Next steps
- See all 7 Nitinol Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTK, Nitinol Medical Technologies, 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.