HDX
9 FDA 510(k) clearances · Product code
167 daysmedian time to decision
559 days90th percentile
9clearances measured
FDA profile
- Official device name
- Dilator, Vaginal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.3900
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Intimate Rose Vaginal Dilators (K241748) | Plus EV Holdings Dba Intimate Rose | 2024-08-14 |
| Hope&Her Vaginal Dilators (K233689) | Lujena, Inc. | 2024-05-02 |
| Hope&Her Vaginal Dilators (K222492) | Lujena, Inc. | 2023-06-27 |
| Intimate Rose Vaginal Dilators (K231430) | Plus EV Holdings Dba Intimate Rose | 2023-06-07 |
| Milli Vaginal Dilator (K220035) | Materna Medical | 2023-02-27 |
| Milli Vaginal Dilator (K211959) | Materna Medical | 2021-12-01 |
| PANPAC VAGINAL DILATORS (K130273) | Panpac Medical Corporation | 2013-08-08 |
| NEO-VAGINA SURGERY SET AND ACCESSORIES (K071754) | KARL STORZ Endoscopy-America, Inc. | 2009-01-07 |
| BIOTEQUE VAGINAL DILATOR (K003380) | Bioteque America, Inc. | 2001-01-29 |
Track HDX automatically
Every clearance here is in the API, with alerts when new ones post.