Suntech Medical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Suntech Medical, Inc.” (first 2005, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 80 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 | 87 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 200 |
| 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 | 6 | 6 |
| DXQ | Blood Pressure Cuff | 2 | 2 |
Review panels
- Cardiovascular (8)
Most recent Suntech Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160439 | SunTech CT40 Spot-check Vital Signs Device | DXN | 2016-07-06 | 140 |
| K151520 | Oscar 2 | DXN | 2016-02-19 | 259 |
| K122401 | TANGO M2 BLOOD PRESSURE MONITOR | DXN | 2012-11-02 | 87 |
| K080854 | DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 | DXQ | 2008-10-20 | 207 |
| K070750 | 247 BP DEVICE | DXN | 2007-05-02 | 44 |
| K060820 | CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 | DXN | 2006-06-07 | 72 |
| K053209 | TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM | DXN | 2006-01-05 | 50 |
| K051904 | ALL PURPOSE CUFF, MODEL 222APC | DXQ | 2005-09-09 | 58 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2020-04-20.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Suntech Medical, Inc. (7)
- Suntech Medical (1)
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 Instruments, Inc. (5 510(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, Inc.?
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Suntech Medical, Inc.” (first 2005, latest 2016), across 2 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 Suntech Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Suntech Medical, Inc. is 80 days.
Which FDA product codes appear under Suntech Medical, Inc.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 6); DXQ (Blood Pressure Cuff, 2).
Next steps
- See all 8 Suntech Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Suntech Medical, 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.