Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ki Mobility, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
281 daysmedian FDA review time
1278 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Foc | Ki Mobility, LLC | 2023-09-05 | 1278 | 0 |
| K201869 | Ki Power Tilt System | Ki Mobility, LLC | 2023-09-05 | 1155 | 0 |
| K223533 | Little Wave Arc; Little Wave Flip | Ki Mobility, LLC | 2023-08-31 | 281 | 0 |
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | Ki Mobility, LLC | 2023-08-31 | 281 | 0 |
| K062660 | CATALYSY | Ki Mobility, LLC | 2006-10-24 | 47 | 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