Globalcare Medical Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Globalcare Medical Technology Co., Ltd.” (first 2020, latest 2026), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 125 days. Since 2017 the median was 125 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 |
|---|---|---|
| 2020 | 2 | 218 |
| 2021 | 0 | — |
| 2022 | 1 | 125 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 81 |
| 2026 | 1 | 89 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Globalcare Medical Technology Co., Ltd. took a median 125 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 | 3 | 3 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 1 | 1 |
Review panels
- Cardiovascular (3)
- Anesthesiology (1)
- Neurology (1)
Most recent Globalcare Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253896 | TENS/EMS device (GUSE01) | NUH | 2026-03-04 | 89 |
| K250136 | Globalcare Blood Pressure Monitor (GUS610) | DXN | 2025-04-08 | 81 |
| K222160 | GUS610 Blood pressure monitor | DXN | 2022-11-22 | 125 |
| K192633 | GUS831 Compressor Nebulizer | CAF | 2020-05-01 | 221 |
| K192609 | Globalcare Blood Pressure Monitor | DXN | 2020-04-21 | 214 |
Recalls
openFDA lists no recalls under a recalling firm named Globalcare Medical Technology Co., Ltd..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Globalcare Medical Technology Co., Ltd. (a text match, not an official crosswalk):
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.
- Globalcare Intl., Inc. (4 510(k)s)
- Globalcare (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Globalcare Medical Technology Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Globalcare Medical Technology Co., Ltd.” (first 2020, latest 2026), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Globalcare Medical Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Globalcare Medical Technology Co., Ltd. is 125 days. Since 2017: 125 days, versus 162 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Globalcare Medical Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3); CAF (Nebulizer (Direct Patient Interface), 1); NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 1).
Next steps
- See all 5 Globalcare Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Globalcare Medical Technology Co., Ltd.'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.