Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HDX — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
167 daysmedian FDA review time
559 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241748 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2024-08-14 | 57 | 0 |
| K233689 | Hope&Her Vaginal Dilators | Lujena, Inc. | 2024-05-02 | 167 | 0 |
| K222492 | Hope&Her Vaginal Dilators | Lujena, Inc. | 2023-06-27 | 314 | 0 |
| K231430 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2023-06-07 | 21 | 0 |
| K220035 | Milli Vaginal Dilator | Materna Medical | 2023-02-27 | 418 | 0 |
| K211959 | Milli Vaginal Dilator | Materna Medical | 2021-12-01 | 160 | 0 |
| K130273 | PANPAC VAGINAL DILATORS | Panpac Medical Corporation | 2013-08-08 | 185 | 0 |
| K071754 | NEO-VAGINA SURGERY SET AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2009-01-07 | 559 | 0 |
| K003380 | BIOTEQUE VAGINAL DILATOR | Bioteque America, Inc. | 2001-01-29 | 90 | 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