FDA product code QYZ: At Home Intravaginal Insemination System
QYZ is the FDA product code for at home intravaginal insemination system. It is a Class II device, regulated under 21 CFR 884.6110 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 3 510(k) submissions under QYZ, 3 in the last five years, from 3 different applicants. The average 510(k) review took 175 days (median 192).
Definition
To deliver semen to the vaginal canal for insemination.
Classification
| Field | Value |
|---|---|
| Device name | At Home Intravaginal Insemination System |
| Device class | Class II |
| Regulation | 21 CFR 884.6110 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for QYZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 3 | 175 |
Compare with all 510(k) review times · Search every QYZ clearance
Top QYZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hannah Life Technologies Pte , Ltd. | 1 | 2023-12-21 |
| Pherdal Fertility Science, Inc. | 1 | 2023-12-14 |
| Mosie Baby | 1 | 2023-11-29 |
Most recent QYZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232579 | Hannah Life Technologies Pte , Ltd. | Twoplus Applicator | 2023-12-21 | 118 |
| K231645 | Pherdal Fertility Science, Inc. | PherDal® At-Home Insemination Kit | 2023-12-14 | 192 |
| K231203 | Mosie Baby | Mosie Baby Kit | 2023-11-29 | 216 |
Recalls for QYZ devices
openFDA lists no recalls for product code QYZ.
Frequently asked questions
What is FDA product code QYZ?
QYZ is the FDA product code for at home intravaginal insemination system. It is a Class II device, regulated under 21 CFR 884.6110 and reviewed by the Obstetrics and Gynecology panel.
What device class is QYZ?
Class II, regulation 21 CFR 884.6110. Typical premarket route: 510(k).
How long does a 510(k) take for product code QYZ?
Across 3 cleared submissions the average was 175 days from receipt to decision (median 192).
Which companies have the most QYZ clearances?
Hannah Life Technologies Pte , Ltd. (1); Pherdal Fertility Science, Inc. (1); Mosie Baby (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QYZ
- Run a recall and safety report across every QYZ manufacturer
- Watch product code QYZ 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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