Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cymedica Orthopedics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
94 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230533 | Motive™ Electrode | Cymedica Orthopedics, Inc. | 2023-03-22 | 23 | 0 |
| K220738 | Motive Knee Wrap | Cymedica Orthopedics, Inc. | 2022-05-12 | 59 | 0 |
| K210604 | Intellihab System | Cymedica Orthopedics, Inc. | 2021-06-03 | 94 | 0 |
| K163067 | CyMedica e-vive™ System; CY-1000 | Cymedica Orthopedics, Inc. | 2016-12-01 | 29 | 0 |
| K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electr | Cymedica Orthopedics, Inc. | 2015-04-02 | 43 | 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