Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oriental Inspiration Limited · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
207 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233046 | Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited | 2024-04-19 | 207 | 0 |
| K213133 | Keffort (MC-100, MC-100A) | Oriental Inspiration Limited | 2022-04-13 | 198 | 0 |
| K212285 | Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, C | Oriental Inspiration Limited | 2021-12-22 | 154 | 0 |
| K170269 | Hee HR Mini | Oriental Inspiration Limited | 2017-05-03 | 96 | 0 |
| K170260 | BC-001+ Acne Purifier | Oriental Inspiration Limited | 2017-04-25 | 88 | 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