Joytech Healthcare Co. , Ltd.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Joytech Healthcare Co. , Ltd.” (first 2017, latest 2026), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 174 days. Since 2017 the median was 174 days, against 180 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 |
|---|---|---|
| 2017 | 3 | 261 |
| 2018 | 3 | 172 |
| 2019 | 4 | 136 |
| 2020 | 2 | 132 |
| 2021 | 0 | — |
| 2022 | 2 | 168 |
| 2023 | 1 | 177 |
| 2024 | 2 | 244 |
| 2025 | 3 | 236 |
| 2026 | 4 | 217 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Joytech Healthcare Co. , Ltd. took a median 174 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 180 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 14 | 14 |
| FLL | Continuous Measurement Thermometer | 7 | 7 |
| HGX | Pump, Breast, Powered | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
Review panels
Most recent Joytech Healthcare Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) | DXN | 2026-08-26 | 119 |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) | DXN | 2026-08-13 | 316 |
| K252501 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) | DXN | 2026-04-28 | 263 |
| K252685 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) | DXN | 2026-02-13 | 171 |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | CAF | 2025-07-02 | 236 |
| K250548 | Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | DXN | 2025-06-26 | 121 |
| K241431 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) | DXN | 2025-01-13 | 237 |
| K241322 | Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) | HGX | 2024-12-19 | 223 |
| K231303 | Arm-type Fully Automatic Digital Blood Pressure Monitor | DXN | 2024-01-26 | 266 |
| K230566 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor | DXN | 2023-08-25 | 177 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Joytech Healthcare 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 Joytech Healthcare Co. , Ltd. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Joytech Healthcare Co. , Ltd.?
FDA lists 24 510(k) clearances under the applicant name “Joytech Healthcare Co. , Ltd.” (first 2017, latest 2026), across 4 product codes in 4 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 Joytech Healthcare Co. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Joytech Healthcare Co. , Ltd. is 174 days. Since 2017: 174 days, versus 180 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Joytech Healthcare Co. , Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 14); FLL (Continuous Measurement Thermometer, 7); HGX (Pump, Breast, Powered, 2).
Next steps
- See all 24 Joytech Healthcare Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Joytech Healthcare 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.