Medical Device Manufacturer · IL , Rishon Letziyon

Perigen, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2025

Total

Cleared

Denied

Perigen, Inc. develops perinatal software solutions designed to support maternal and fetal safety during labor and delivery. The company creates advanced technology platforms that help clinical teams identify potential risks early and improve patient outcomes. Perigen operates with a manufacturing facility in Rishon Letziyon, IL.

Perigen has received 1 FDA 510(k) clearance from 1 total submission. The company specializes exclusively in Obstetrics & Gynecology devices. First cleared in 2025, Perigen remains actively engaged in regulatory submissions and product development.

The company's cleared device, PeriCALM Patterns 3.0, represents its focus on clinical decision support and surveillance systems for obstetric care. Perigen supports over 750,000 births annually across the United States and Canada through solutions deployed in more than 500 hospitals. The company is now part of Halma plc, a global group of purpose-driven technology companies.

Explore the complete regulatory record, including device names, product codes, and clearance dates, in the 510(k) database.

FDA 510(k) Regulatory Record - Perigen, Inc.

1 devices

1-1 of 1

Cleared Jan 10, 2025

PeriCALM Patterns 3.0

K241009 · HGM

Obstetrics & Gynecology · 273d

Perigen, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Perigen, Inc.

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