Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Osto Technology Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
430 daysmedian FDA review time
441 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212989 | Low-frequency Stimulator (Model: AST-645, AST-646) | Shenzhen Osto Technology Co., Ltd. | 2021-11-22 | 63 | 0 |
| K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST- | Shenzhen Osto Technology Co., Ltd. | 2019-10-10 | 430 | 0 |
| K172897 | Neck Care Therapy, Model: SYK 509B | Shenzhen Osto Technology Co., Ltd. | 2018-12-07 | 441 | 0 |
| K172837 | Low-frequency Multi-function physiotherapy instrument | Shenzhen Osto Technology Co., Ltd. | 2018-11-26 | 433 | 0 |
| K172834 | Dual output digital therapy massager | Shenzhen Osto Technology Co., Ltd. | 2018-09-06 | 352 | 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