Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cycling and Health Tech. Industry R&D Center/Chc · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052558 | VCS, MODEL S4T | Cycling and Health Tech. Industry R&D Center/Chc | 2005-10-27 | 41 | 0 |
| K051130 | VCS S3Y | Cycling and Health Tech. Industry R&D Center/Chc | 2005-09-09 | 129 | 0 |
| K051131 | VCS S3T | Cycling and Health Tech. Industry R&D Center/Chc | 2005-08-15 | 104 | 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