Company · US
Clinical Innovations, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2025. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
8recalls (1 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | 5 |
| HDB | Extractor, Vacuum, Fetal | 4 |
| HFN | Transducer, Pressure, Intrauterine | 4 |
| OQY | Intrauterine Tamponade Balloon | 4 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 |
| NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 2 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 |
| HDP | Elevator, Uterine | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 |
| HFX | Clamp, Circumcision | 1 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2025 | K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Tract Clinical Innovations, LLC | HDB |
| May 22, 2025 | K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) Clinical Innovations, LLC | HFN |
| Feb 24, 2023 | K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) Clinical Innovations, LLC | FMK |
| Jan 14, 2016 | K153591 | ebb Complete Tamponade System Clinical Innovations, LLC | OQY |
| Mar 25, 2015 | K150573 | ebb Complete Tamponade System Clinical Innovations, LLC | OQY |
| May 29, 2014 | K140163 | KOALA TOCO Clinical Innovations, LLC | HFM |
| May 28, 2014 | K131781 | CLEARVIEW TOTAL Clinical Innovations, LLC | LKF |
| Nov 23, 2011 | K110605 | ROM PLUS Clinical Innovations, LLC | NQM |
| Sep 20, 2007 | K061539 | GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE Clinical Innovations, LLC | HFX |
| Sep 17, 2003 | K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 Clinical Innovations, Inc. | HGP |
| Jan 7, 2003 | K022023 | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 Clinical Innovations, Inc. | KLA |
| May 3, 2001 | K003458 | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 Clinical Innovations, Inc. | HGP |
| Sep 22, 1998 | K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M Clinical Innovations, Inc. | HDB |
| Mar 2, 1998 | K974563 | COLPO CUP CVC-2000 Clinical Innovations, Inc. | HDP |
| Feb 19, 1998 | K974389 | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER Clinical Innovations, Inc. | HFN |
| Nov 24, 1997 | K973746 | PRE-FILLED SYRINGE FOR KOALA IUP Clinical Innovations, Inc. | HFN |
| Apr 17, 1996 | K954955 | STORC INTRAUTERINE PRESSURE CATHETER Clinical Innovations, Inc. | HFN |
| Jul 26, 1994 | K940681 | CLEARVIEW UTERINE MANIPULATOR Clinical Innovations, Inc. | LKF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2026 | Clinical Innovations, LLC 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 Open, Classified |
HDB | K981260 |
| Aug 13, 2020 | Clinical Innovations, LLC Clinical Innovations ROM Plus Collection Kit
IFU:
ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 Terminated |
NQM | K110605 |
| Aug 6, 2019 | Clinical Innovations, LLC Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system. Terminated |
HDB | K981260 |
| May 30, 2019 | Clinical Innovations, LLC 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* Terminated |
LKF | K131781 |
| Oct 15, 2015 | Clinical Innovations, LLC The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY.
Intended for use in providing temporary control or reduction of postpartum uterine bleeding. Terminated |
OQY | K150573 |
| Jan 27, 2015 | Clinical Innovations, LLC Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO Terminated |
OQY | None listed |
| Sep 2, 2008 | Clinical Innovations, LLC ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123. Terminated |
LKF | K940681 |
| Sep 2, 2008 | Clinical Innovations, LLC 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. Terminated |
LKF | K940681 |