FDA product code PBH: Embryo Image Assessment System, Assisted Reproduction
PBH is the FDA product code for embryo image assessment system, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6195 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 4 510(k) submissions under PBH, 2 in the last five years, from 4 different applicants. The average 510(k) review took 268 days (median 266); 334 days on average over the last three years. 1 De Novo request was granted under it.
Definition
The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .
Classification
| Field | Value |
|---|---|
| Device name | Embryo Image Assessment System, Assisted Reproduction |
| Device class | Class II |
| Regulation | 21 CFR 884.6195 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for PBH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 290 |
| 2025 | 1 | 242 |
| 2026 | 1 | 427 |
Compare with all 510(k) review times · Search every PBH clearance
Top PBH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alife Health | 1 | 2026-05-15 |
| Fairtility , Ltd. | 1 | 2025-08-15 |
| Vitrolife A/S | 1 | 2019-07-19 |
| Auxogyn, Inc. | 1 | 2014-11-24 |
Most recent PBH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250781 | Alife Health | Embryo Predict | 2026-05-15 | 427 |
| K243851 | Fairtility , Ltd. | CHLOE BLAST | 2025-08-15 | 242 |
| K182798 | Vitrolife A/S | KIDScore D3 | 2019-07-19 | 290 |
| K142147 | Auxogyn, Inc. | EEVA SYSTEM | 2014-11-24 | 111 |
Recalls for PBH devices
openFDA lists no recalls for product code PBH.
Frequently asked questions
What is FDA product code PBH?
PBH is the FDA product code for embryo image assessment system, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6195 and reviewed by the Obstetrics and Gynecology panel.
What device class is PBH?
Class II, regulation 21 CFR 884.6195. Typical premarket route: 510(k).
How long does a 510(k) take for product code PBH?
Across 4 cleared submissions the average was 268 days from receipt to decision (median 266).
Which companies have the most PBH clearances?
Alife Health (1); Fairtility , Ltd. (1); Vitrolife A/S (1); Auxogyn, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PBH
- Run a recall and safety report across every PBH manufacturer
- Watch product code PBH 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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