# Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 36/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262090 |
| Device | Fertilis microICSI Device |
| Applicant | Fertilis Pty, Ltd. |
| Specialty / panel | Obstetrics/Gynecology |
| Product code | MQK |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-22 |
| Decision date | 2026-10-09 |
| Review time (days) | 109 |
| Third-party review | No |
| Applicant location | Adelaide, AU |

## Why this score
- Fast 109-day review: this device is a strong predicate for similar products.
- Posted 26 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262090). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.