FDA product code HDR: Cap, Cervical
HDR is the FDA product code for cap, cervical. It is a Class II device, regulated under 21 CFR 884.5250 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 29 510(k) submissions under HDR, 2 in the last five years, from 17 different applicants. The average 510(k) review took 111 days (median 79); 265 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Cap, Cervical |
| Device class | Class II |
| Regulation | 21 CFR 884.5250 |
| 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 HDR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 269 |
| 2025 | 1 | 265 |
Compare with all 510(k) review times · Search every HDR clearance
Top HDR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Irvine Scientific | 9 | 1990-04-16 |
| Pharmacia, Inc. | 3 | 1990-10-05 |
| Cook Ob/Gyn | 3 | 1990-08-28 |
| Stepone Fertility Ltd (T/A Béa Fertility) | 1 | 2025-04-02 |
| Rosesta Medical BV | 1 | 2023-06-23 |
12 more applicants have HDR clearances. See the full list in Caduvo.
Most recent HDR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242031 | Stepone Fertility Ltd (T/A Béa Fertility) | Béa Applicator (BAP-GB-01) | 2025-04-02 | 265 |
| K222969 | Rosesta Medical BV | FERTI-LILY Conception Cup | 2023-06-23 | 269 |
| K993953 | Veos , Ltd. | OVES CERVICAL CAP | 2000-03-21 | 120 |
| K945131 | Imagyn Medical, Inc. | IMAGYN INTRAUTERINE INSEMINATION DEVICE | 1995-05-15 | 208 |
| K950714 | Cook Urological, Inc. | COOK INSEMINATION CUP | 1995-05-11 | 85 |
Recalls for HDR devices
openFDA lists no recalls for product code HDR.
Frequently asked questions
What is FDA product code HDR?
HDR is the FDA product code for cap, cervical. It is a Class II device, regulated under 21 CFR 884.5250 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDR?
Class II, regulation 21 CFR 884.5250. Typical premarket route: 510(k).
How long does a 510(k) take for product code HDR?
Across 29 cleared submissions the average was 111 days from receipt to decision (median 79).
Which companies have the most HDR clearances?
Irvine Scientific (9); Pharmacia, Inc. (3); Cook Ob/Gyn (3); Stepone Fertility Ltd (T/A Béa Fertility) (1); Rosesta Medical BV (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HDR
- Run a recall and safety report across every HDR manufacturer
- Watch product code HDR 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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