K250298 is an FDA 510(k) clearance for the Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M). This device is classified as a Extractor, Vacuum, Fetal (Class II - Special Controls, product code HDB).
Submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on October 8, 2025, 250 days after receiving the submission on January 31, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4340.
| 510(k) Number | K250298 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2025 |
| Decision Date | October 08, 2025 |
| Days to Decision | 250 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDB - Extractor, Vacuum, Fetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4340 |