Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smartmissimo Technologies Pte, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
258 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210938 | PowerDot PD-01MT2 Muscle Stimulator | Smartmissimo Technologies Pte, Ltd. | 2021-07-30 | 123 | 0 |
| K210269 | PowerDot PD-01MT2 Muscle Stimulator | Smartmissimo Technologies Pte, Ltd. | 2021-02-23 | 22 | 0 |
| K181759 | PowerDot PD-01MT | Smartmissimo Technologies Pte, Ltd. | 2018-11-09 | 130 | 0 |
| K172876 | PowerDot PD-01M | Smartmissimo Technologies Pte, Ltd. | 2017-12-04 | 74 | 0 |
| K150078 | PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile | Smartmissimo Technologies Pte, Ltd. | 2015-09-30 | 258 | 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