FDA product code POV: Semen Analysis Device
POV is the FDA product code for semen analysis device. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Hematology panel. FDA has cleared 28 510(k) submissions under POV, 6 in the last five years, from 16 different applicants. The average 510(k) review took 193 days (median 147); 230 days on average over the last three years. FDA has posted 2 recalls for POV devices, 2 initiated in the last five years.
Definition
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.
Classification
| Field | Value |
|---|---|
| Device name | Semen Analysis Device |
| Device class | Class II |
| Regulation | 21 CFR 864.5220 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for POV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 88 |
| 2018 | 1 | 282 |
| 2019 | 1 | 183 |
| 2020 | 1 | 92 |
| 2023 | 1 | 503 |
| 2024 | 1 | 176 |
| 2025 | 3 | 246 |
| 2026 | 1 | 267 |
Compare with all 510(k) review times · Search every POV clearance
Top POV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Electronic Systems , Ltd. | 5 | 2025-05-02 |
| Bonraybio Co., Ltd. | 4 | 2025-05-30 |
| Sandstone Diagnostics, Inc. | 2 | 2017-11-17 |
| Princeton BioMeditech Corp. | 2 | 2010-05-04 |
| Medical Electronic Systems, LLC | 2 | 2002-09-20 |
11 more applicants have POV clearances. See the full list in Caduvo.
Most recent POV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252228 | Checkcells, Inc. | Seaman Pro/Seaman | 2026-04-09 | 267 |
| K242830 | Bonraybio Co., Ltd. | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | 2025-05-30 | 253 |
| K242388 | Bonraybio Co., Ltd. | LensHooke X12 PRO Semen Analysis System | 2025-05-09 | 270 |
| K243114 | Medical Electronic Systems , Ltd. | SQA-iOw Sperm Quality Analyzer | 2025-05-02 | 214 |
| K241628 | Medical Electronic Systems , Ltd. | YO Home Sperm Test | 2024-11-29 | 176 |
Recalls for POV devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code POV?
POV is the FDA product code for semen analysis device. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Hematology panel.
What device class is POV?
Class II, regulation 21 CFR 864.5220. Typical premarket route: 510(k).
How long does a 510(k) take for product code POV?
Across 28 cleared submissions the average was 193 days from receipt to decision (median 147).
Which companies have the most POV clearances?
Medical Electronic Systems , Ltd. (5); Bonraybio Co., Ltd. (4); Sandstone Diagnostics, Inc. (2); Princeton BioMeditech Corp. (2); Medical Electronic Systems, LLC (2).
Have POV devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code POV
- Run a recall and safety report across every POV manufacturer
- Watch product code POV 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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