Clinical Innovations, LLC
Murray, UT, US
CLINICAL INNOVATIONS, LLC appears in FDA device records in Murray, UT. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Clinical Innovations, LLC between 1994 and 2025. The busiest year on record is 1998, with 3. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 3 |
| 2001 | 1 |
| 2003 | 2 |
| 2007 | 1 |
| 2011 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | Substantially Equivalent | |
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | HFN | Substantially Equivalent | |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) | FMK | Substantially Equivalent | |
| K153591 | ebb Complete Tamponade System | OQY | Substantially Equivalent | |
| K150573 | ebb Complete Tamponade System | OQY | Substantially Equivalent | |
| K140163 | KOALA TOCO | HFM | Substantially Equivalent | |
| K131781 | CLEARVIEW TOTAL | LKF | Substantially Equivalent | |
| K110605 | ROM PLUS | NQM | Substantially Equivalent | |
| K061539 | GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE | HFX | Substantially Equivalent | |
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | HGP | Substantially Equivalent | |
| K022023 | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 | KLA | Substantially Equivalent | |
| K003458 | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 | HGP | Substantially Equivalent | |
| K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M | HDB | Substantially Equivalent | |
| K974563 | COLPO CUP CVC-2000 | HDP | Substantially Equivalent | |
| K974389 | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER | HFN | Substantially Equivalent | |
| K973746 | PRE-FILLED SYRINGE FOR KOALA IUP | HFN | Substantially Equivalent | |
| K954955 | STORC INTRAUTERINE PRESSURE CATHETER | HFN | Substantially Equivalent | |
| K940681 | CLEARVIEW UTERINE MANIPULATOR | LKF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1722684 | 1000220650 | CLINICAL INNOVATIONS, LLC | 747 W 4170 S, MURRAY, UT 84123 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LKFCannula, Manipulator/Injector, Uterine
- HFXClamp, Circumcision
- FENDevice, Cystometric, Hydraulic
- KMKDevice, Intravascular Catheter Securement
- PJHDynamic Rectal Control System
- HGPElectrode, Circular (Spiral), Scalp And Applicator
- HDPElevator, Uterine
- HDBExtractor, Vacuum, Fetal
- NQMImmunoassay For Detection Of Amniotic Fluid Protein(S).
- OQYIntrauterine Tamponade Balloon
- KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- CCXSupport, Patient Position
- KGXTape And Bandage, Adhesive
- HFNTransducer, Pressure, Intrauterine
- BYYTube, Aspirating, Flexible, Connecting
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1945-2026 | Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator. | Due to complaints of device breakage at the traction force gauge to handle joint. | Class II | Open, Classified | |
| 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 diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur. | Class II | Terminated | |
| Z-2072-2020 | Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system. | There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system. | Class II | Terminated | |
| Z-2118-2020 | Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled. | An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury. | Class II | Terminated | |
| Z-0123-2016 | The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding. | Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed. | Class II | Terminated | |
| Z-1014-2015 | Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO | Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014. | Class II | Terminated | |
| Z-1818-2008 | ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123. | Inadequate package seal could compromise sterility. | Terminated | ||
| Z-1817-2008 | ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123. | Inadequate package seal could compromise sterility. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain