APK Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “APK Technology Co., Ltd.” (first 1991, latest 2025), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 186 days. Since 2017 the median was 60 days, against 175 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 60 |
| 2018 | 1 | 254 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 52 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name APK Technology Co., Ltd. took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 2 | 2 |
| LRP | Tray, Surgical | 2 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| FTC | Light, Ultraviolet, Dermatological | 1 | 1 |
Review panels
Most recent APK Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250425 | Ultraviolet Phototherapy Device | FTC | 2025-04-07 | 52 |
| K172981 | Reusable SpO2 Sensors, Disposable SpO2 Sensors | DQA | 2018-06-08 | 254 |
| K170536 | ECG Disposable Lead Wire | DSA | 2017-04-24 | 60 |
| K102825 | BLOOD PRESSURE CUFF | DXQ | 2011-03-02 | 154 |
| K082846 | APK SPO2 PULSE OXIMETER SENSOR | DQA | 2009-04-03 | 186 |
| K903963 | KITS AND TRAYS FOR ONE TIME USE ONLY | LRP | 1991-07-29 | 335 |
| K903962 | INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE | LRP | 1991-07-29 | 335 |
Recalls
openFDA lists no recalls under a recalling firm named APK 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under APK Technology Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “APK Technology Co., Ltd.” (first 1991, latest 2025), across 5 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 APK Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name APK Technology Co., Ltd. is 186 days. Since 2017: 60 days, versus 175 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under APK Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 2); LRP (Tray, Surgical, 2); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 1).
Next steps
- See all 7 APK Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQA, APK 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.