Murray, UT, US · 3 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HDB | — | — | — | 1 | 2025-10-08 |
| HFN | Transducer, Pressure, Intrauterine | Class II | Obstetrics/Gynecology | 1 | 2025-05-22 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class II | General, Plastic Surgery | 1 | 2023-02-24 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-03-09 | Class II | Ongoing | Z-1945-2026 | Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-60… | — | Due to complaints of device breakage at the traction force gauge to handle joint. |
| 2020-08-13 | Class II | Terminated | Z-0541-2021 | Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 | — | Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnosti… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-10-08 | K250298 | 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) | HDB | — | — |
| 2025-05-22 | K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | HFN | Class II | Obstetrics/Gynecology |
| 2023-02-24 | K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) | FMK | Class II | General, Plastic Surgery |