Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cycling and Health Tech. Industry R&D Center · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
129 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050507 | SMARTECH, MODEL HOLI I | Cycling and Health Tech. Industry R&D Center | 2005-07-07 | 129 | 0 |
| K050793 | LANDLEX MODEL S400X | Cycling and Health Tech. Industry R&D Center | 2005-07-07 | 101 | 0 |
| K050792 | LANDLEX, MODEL S300X | Cycling and Health Tech. Industry R&D Center | 2005-04-21 | 24 | 0 |
| K043326 | BEWELL, MODEL SC 20 | Cycling and Health Tech. Industry R&D Center | 2005-01-26 | 55 | 0 |
| K043332 | WHEELCHAIR, MODEL 8500-II | Cycling and Health Tech. Industry R&D Center | 2004-12-13 | 11 | 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