K250897 is an FDA 510(k) clearance for the Koala Intrauterine Pressure Catheter (IPC-5000E). This device is classified as a Transducer, Pressure, Intrauterine (Class II - Special Controls, product code HFN).
Submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on May 22, 2025, 58 days after receiving the submission on March 25, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2700.
| 510(k) Number | K250897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2025 |
| Decision Date | May 22, 2025 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFN - Transducer, Pressure, Intrauterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2700 |