Data / Medical devices / United States / Clinical Innovations, LLC
Clinical Innovations, LLC: FDA-registered device maker in Murray, UT, United States, 12 510(k) clearances
Clinical Innovations, LLC is registered with the FDA (registration 1722684) in Murray, UT, United States. It lists 15 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 8, 2025. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1722684
- FEI number
- 1000220650
- Address
- 747 W 4170 S, Murray, UT, United States, 84123
- Owner or operator
- Clinical Innovations, LLC (10035300)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- February 17, 2011
- Registered through
- 2026
- Brand names listed
- ABBy Postoperative Panniculus Retractor, AIR-CHARGED CATHETERS, AccuCirc, BoogieBaby, ClearView Total, Clearview Uterine Manipulator, Eclipse System, Kiwi and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Manipulator/Injector, Uterine | LKF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Clamp, Circumcision | HFX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Cystometric, Hydraulic | FEN | 2 | Contract manufacturer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Dynamic Rectal Control System | PJH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrode, Circular (Spiral), Scalp And Applicator | HGP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Extractor, Vacuum, Fetal | HDB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Immunoassay For Detection Of Amniotic Fluid Protein(S). | NQM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Uterine Contraction, External (For Use In Clinic) | HFM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Transducer, Pressure, Intrauterine | HFN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 8, 2025 | 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 | Clinical Innovations, LLC | accessdata.fda.gov |
| May 22, 2025 | K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | HFN | Substantially Equivalent | Clinical Innovations, LLC | accessdata.fda.gov |
| February 24, 2023 | K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) | FMK | Substantially Equivalent | Clinical Innovations, LLC | accessdata.fda.gov |
| November 12, 2015 | K150558 | Eclipse System | PJH | Substantially Equivalent | Pelvalon, Inc. | accessdata.fda.gov |
| May 29, 2014 | K140163 | KOALA TOCO | HFM | Substantially Equivalent | Clinical Innovations, LLC | accessdata.fda.gov |
| May 28, 2014 | K131781 | CLEARVIEW TOTAL | LKF | Substantially Equivalent | Clinical Innovations, LLC | accessdata.fda.gov |
| November 23, 2011 | K110605 | ROM PLUS | NQM | Substantially Equivalent | Clinical Innovations, LLC | accessdata.fda.gov |
| September 20, 2007 | K061539 | GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE | HFX | Substantially Equivalent | Clinical Innovations, LLC | accessdata.fda.gov |
| September 17, 2003 | K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | HGP | Substantially Equivalent | Clinical Innovations, Inc. | accessdata.fda.gov |
| September 22, 1998 | K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M | HDB | Substantially Equivalent | Clinical Innovations, Inc. | accessdata.fda.gov |
| February 19, 1998 | K974389 | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER | HFN | Substantially Equivalent | Clinical Innovations, Inc. | accessdata.fda.gov |
| July 26, 1994 | K940681 | CLEARVIEW UTERINE MANIPULATOR | LKF | Substantially Equivalent | Clinical Innovations, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 9, 2026 | 98597 | Class II | Ongoing | 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 delive | Due to complaints of device breakage at the traction force gauge to handle joint. | accessdata.fda.gov |
| August 13, 2020 | 86255 | Class II | Terminated | 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. | accessdata.fda.gov |
| August 6, 2019 | 85170 | Class II | Terminated | 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. | accessdata.fda.gov |
| May 30, 2019 | 85144 | Class II | Terminated | 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* * *." | 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. | accessdata.fda.gov |
| January 5, 2015 | 72018 | Class II | Terminated | 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. | accessdata.fda.gov |
| December 30, 2014 | 70137 | Class II | Terminated | 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. | accessdata.fda.gov |
| May 12, 2008 | 48115 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Circular (Spiral), Scalp And Applicator
- All makers of Support, Patient Position
- All makers of Extractor, Vacuum, Fetal
- All makers of Device, Cystometric, Hydraulic
- All makers of Cannula, Manipulator/Injector, Uterine
- All makers of Transducer, Pressure, Intrauterine
Updated April 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.