Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tung Keng Enterprise Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
261 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220156 | Electrically Powered Wheelchair, Joy Rider | Tung Keng Enterprise Co., Ltd. | 2022-10-07 | 261 | 0 |
| K033220 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280 | Tung Keng Enterprise Co., Ltd. | 2003-12-18 | 76 | 0 |
| K033240 | BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200 | Tung Keng Enterprise Co., Ltd. | 2003-12-18 | 73 | 2 |
| K033219 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600 | Tung Keng Enterprise Co., Ltd. | 2003-11-12 | 40 | 0 |
| K033239 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 | Tung Keng Enterprise Co., Ltd. | 2003-11-12 | 37 | 0 |
| K033241 | BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320 | Tung Keng Enterprise Co., Ltd. | 2003-11-10 | 35 | 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