Grandway Technology (Shenzhen) Limited: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Grandway Technology (Shenzhen) Limited” (first 2011, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 104 days. Since 2017 the median was 162 days, against 162 days for all cleared 510(k)s in the same product codes. 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 | 4 | 254 |
| 2014 | 4 | 100 |
| 2015 | 7 | 94 |
| 2016 | 0 | — |
| 2017 | 3 | 162 |
| 2018 | 1 | 334 |
| 2019 | 1 | 38 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Grandway Technology (Shenzhen) Limited took a median 162 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 21 | 21 |
Review panels
- Cardiovascular (21)
Most recent Grandway Technology (Shenzhen) Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191593 | Digital Automatic Blood Pressure Monitor MD36 Series | DXN | 2019-07-22 | 38 |
| K171379 | Digital Automatic Wrist Blood Pressure Monitor MD4300 | DXN | 2018-04-10 | 334 |
| K163648 | Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series | DXN | 2017-07-07 | 196 |
| K163679 | Digital Automatic Blood Pressure Monitor MD3600 | DXN | 2017-06-07 | 162 |
| K163113 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series | DXN | 2017-01-19 | 73 |
| K152483 | Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series | DXN | 2015-09-29 | 29 |
| K151587 | Digital Automatic Wrist Blood Pressure Monitor MD3200 | DXN | 2015-08-07 | 57 |
| K151583 | Digital Automatic Wrist Blood Pressure Monitor MD3900 | DXN | 2015-08-07 | 57 |
| K143735 | Digital Automatic Blood Pressure Monitor MD2300 | DXN | 2015-07-23 | 205 |
| K150373 | Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] | DXN | 2015-06-11 | 118 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Grandway Technology (Shenzhen) Limited.
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 Grandway Technology (Shenzhen) Limited?
FDA lists 21 510(k) clearances under the applicant name “Grandway Technology (Shenzhen) Limited” (first 2011, latest 2019), 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 Grandway Technology (Shenzhen) Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Grandway Technology (Shenzhen) Limited is 104 days. Since 2017: 162 days, versus 162 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Grandway Technology (Shenzhen) Limited?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 21).
Next steps
- See all 21 Grandway Technology (Shenzhen) Limited clearances with predicates and recalls
- Run predicate analysis for product code DXN, Grandway Technology (Shenzhen) Limited'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.