Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
APK Technology Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
254 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250425 | Ultraviolet Phototherapy Device | APK Technology Co., Ltd. | 2025-04-07 | 52 | 0 |
| K172981 | Reusable SpO2 Sensors, Disposable SpO2 Sensors | APK Technology Co., Ltd. | 2018-06-08 | 254 | 0 |
| K170536 | ECG Disposable Lead Wire | APK Technology Co., Ltd. | 2017-04-24 | 60 | 0 |
| K102825 | BLOOD PRESSURE CUFF | APK Technology Co., Ltd. | 2011-03-02 | 154 | 0 |
| K082846 | APK SPO2 PULSE OXIMETER SENSOR | APK Technology Co., Ltd. | 2009-04-03 | 186 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda