Suntech Medical Instruments, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Suntech Medical Instruments, Inc.” (first 1992, latest 2001), across 1 product code in 1 review panel. Median 510(k) review time under this name: 317 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Suntech Medical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010622 | PRESSURE TRAK, MODEL 222-B | DXN | 2001-03-29 | 27 |
| K003004 | OSCAR 2, MODEL 222 | DXN | 2000-10-25 | 30 |
| K970629 | TANGO NON-INVASIVE BLOOD PRESSURE MONITOR | DXN | 1998-01-02 | 317 |
| K914260 | 4240 DYNAMIC BP/HEART RATE MONITOR | DXN | 1992-09-04 | 347 |
| K913844 | ACCUTRACKER DX | DXN | 1992-07-14 | 321 |
Recalls
openFDA lists no recalls under a recalling firm named Suntech Medical Instruments, 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.
- Suntech Medical, Inc. (8 510(k)s)
- Suntech UK , Ltd. (2 510(k)s)
- Suntech USA, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Suntech Medical Instruments, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Suntech Medical Instruments, Inc.” (first 1992, latest 2001), 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 Suntech Medical Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Suntech Medical Instruments, Inc. is 317 days.
Which FDA product codes appear under Suntech Medical Instruments, Inc.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 5).
Next steps
- See all 5 Suntech Medical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Suntech Medical Instruments, 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.