Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KXQ · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142304 | Viberect Penile Vibratory Stimulation Device | Reflexonic, LLC | 2014-10-03 | 46 | 0 |
| K110566 | VIBERECT PENILE VIBRATORY STIMULATION DEVICE | Reflexonic, LLC | 2011-06-24 | 116 | 0 |
| K010096 | MULTI CARE THERAPEUTIC VIBRATOR | Multicept A/S | 2001-03-05 | 53 | 0 |
| K955589 | FERTICARE PERSONAL THERAPEUTIC VIBRATOR | Multicept, Aps. | 1996-04-11 | 126 | 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