Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Osto Technology Company Limited — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
272 daysmedian FDA review time
353 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213056 | LED Facial Mask | Shenzhen Osto Technology Company Limited | 2022-07-07 | 288 | 0 |
| K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AS | Shenzhen Osto Technology Company Limited | 2021-12-13 | 173 | 0 |
| K211736 | Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST | Shenzhen Osto Technology Company Limited | 2021-09-05 | 90 | 0 |
| K210756 | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H | Shenzhen Osto Technology Company Limited | 2021-06-11 | 88 | 0 |
| K190783 | Health Expert Electronic Stimulator (model: AST-300L) | Shenzhen Osto Technology Company Limited | 2020-03-14 | 353 | 0 |
| K190673 | Health Expert Electronic Stimulator | Shenzhen Osto Technology Company Limited | 2019-12-12 | 272 | 0 |
| K133929 | HEALTH EXPERT ELCTRONIC STIMULATOR | Shenzhen Osto Technology Company Limited | 2014-11-12 | 324 | 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