Clinical Innovations, LLC · Class II · Cleared Oct 8, 2025
| K-number | K250298 |
| Device name | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) |
| Applicant | Clinical Innovations, LLC |
| Product code | HDB |
| Device class | Class II |
| Decision date | Oct 8, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 884.4340 |
The Kiwi Complete Vacuum Delivery System is a fetal vacuum extractor used to assist vaginal delivery during labor. It includes four cup models (OmniCup standard and with traction force indicator, OmniC Cup for cesarean section, and ProCup) that attach to a manual hand pump with a color-coded vacuum gauge. The device is indicated for prolonged second stage of labor, presumed fetal jeopardy not considered severe, or elective shortening of the second stage for selected maternal or fetal conditions.
The subject device differs from the predicate in offering four distinct cup models versus predicate specifications not publicly available, with specific dimensional ranges (overall length 10.5–13.87 inches, width 6.09 inches, handle width 4.20 inches) and an operating vacuum range of 450–600 mmHg with pull-off force ≥20 lbf. The MT variant includes a traction force indicator, and the C variant has a lower-profile cup with finger grooves and baffle filter designed for cesarean delivery.
Testing included ISO 11137-1:2006 and ISO 11137-2:2013 for radiation sterilization validation to SAL 10⁻⁶, ASTM F1980 for shelf-life accelerated aging, ASTM D4169-22 for transportation testing, and ISO 10993 standards (parts 5, 10, 11, 23) plus USP <151> for biocompatibility and pyrogenicity. Design verification included dimensional, leak, bond strength, pop-off force, gauge accuracy, and vacuum performance testing.
Although the subject and predicate devices differ in indications for use wording, models, dimensions, and performance specifications, the applicant argues these differences do not represent new intended uses or raise different safety and effectiveness questions. The indications for use are substantively similar (fetal vacuum extraction under comparable clinical conditions), and performance testing demonstrates the subject device is as safe and effective as the predicate device K981260.
View the full FDA submission: accessdata.fda.gov