FDA product code HDX: Dilator, Vaginal
HDX is the FDA product code for dilator, vaginal. It is a Class II device, regulated under 21 CFR 884.3900 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 9 510(k) submissions under HDX, 5 in the last five years, from 6 different applicants. The average 510(k) review took 219 days (median 167); 112 days on average over the last three years. FDA has posted 1 recall for HDX devices.
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Vaginal |
| Device class | Class II |
| Regulation | 21 CFR 884.3900 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HDX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 160 |
| 2023 | 3 | 251 |
| 2024 | 2 | 112 |
Compare with all 510(k) review times · Search every HDX clearance
Top HDX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Plus EV Holdings Dba Intimate Rose | 2 | 2024-08-14 |
| Lujena, Inc. | 2 | 2024-05-02 |
| Materna Medical | 2 | 2023-02-27 |
| Panpac Medical Corporation | 1 | 2013-08-08 |
| KARL STORZ Endoscopy-America, Inc. | 1 | 2009-01-07 |
1 more applicants have HDX clearances. See the full list in Caduvo.
Most recent HDX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241748 | Plus EV Holdings Dba Intimate Rose | Intimate Rose Vaginal Dilators | 2024-08-14 | 57 |
| K233689 | Lujena, Inc. | Hope&Her Vaginal Dilators | 2024-05-02 | 167 |
| K222492 | Lujena, Inc. | Hope&Her Vaginal Dilators | 2023-06-27 | 314 |
| K231430 | Plus EV Holdings Dba Intimate Rose | Intimate Rose Vaginal Dilators | 2023-06-07 | 21 |
| K220035 | Materna Medical | Milli Vaginal Dilator | 2023-02-27 | 418 |
Recalls for HDX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-06-19.
Frequently asked questions
What is FDA product code HDX?
HDX is the FDA product code for dilator, vaginal. It is a Class II device, regulated under 21 CFR 884.3900 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDX?
Class II, regulation 21 CFR 884.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code HDX?
Across 9 cleared submissions the average was 219 days from receipt to decision (median 167).
Which companies have the most HDX clearances?
Plus EV Holdings Dba Intimate Rose (2); Lujena, Inc. (2); Materna Medical (2); Panpac Medical Corporation (1); KARL STORZ Endoscopy-America, Inc. (1).
Have HDX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-06-19.
Next steps
- Run an FDA pathway report with predicate devices for product code HDX
- Run a recall and safety report across every HDX manufacturer
- Watch product code HDX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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