K241009 is an FDA 510(k) clearance for the PeriCALM Patterns 3.0, a System, Monitoring, Perinatal (Class II — Special Controls, product code HGM), submitted by Perigen, Inc. (Rishon Letziyon, IL). The FDA issued a Cleared decision on January 10, 2025, 273 days after receiving the submission on April 12, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K241009 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 12, 2024 |
| Decision Date | January 10, 2025 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGM — System, Monitoring, Perinatal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.2740 |