# Clinical Innovations, Inc.

- Location (FDA's records): Murray, UT
- FDA decisions: 18 (1994–2025): 18 510(k) clearances
- Names in FDA's records: Clinical Innovations, Inc. (9); Clinical Innovations, LLC (9)
- Product codes: HFN (4), OQY (2), LKF (2), HGP (2), HDB (2), KLA (1), NQM (1), FMK (1), HFX (1), HFM (1), HDP (1)
- Predicates its devices cite: 26 (4 its own); citations of its devices by later devices: 12 (4 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Neward Enterprises, Inc.: 3 (https://510kreport.com/company/neward-enterprises)
- Graphic Controls Corp.: 2 (https://510kreport.com/company/graphic-controls)
- Glenveigh Surgical, LLC: 1 (https://510kreport.com/company/glenveigh-surgical)
- N-Dia, Inc.: 1 (https://510kreport.com/company/n-dia)
- Amnisure International, LLC: 1 (https://510kreport.com/company/amnisure-international)
- Medix Biochemica: 1 (https://510kreport.com/company/medix-biochemica)
- Pro-Lab, Inc.: 1 (https://510kreport.com/company/pro-lab)
- Common Sense, Ltd.: 1 (https://510kreport.com/company/common-sense)

## Firms that cite its devices most
- Philips Medizin Systeme Boeblingen GmbH: 1 (https://510kreport.com/company/philips-medizin-systeme-boeblingen)
- Laborie Medical Technologies, Ltd.: 1 (https://510kreport.com/company/laborie-medical-technologies)
- Medspira, LLC: 1 (https://510kreport.com/company/medspira)
- Medevco, Inc.: 1 (https://510kreport.com/company/medevco)
- Barnev, Ltd.: 1 (https://510kreport.com/company/barnev)
- Neoventa Medical AB: 1 (https://510kreport.com/company/neoventa-medical)
- Beijing Hangtian Kadi Technology R&D Institute: 1 (https://510kreport.com/company/beijing-hangtian-kadi-technology-r-d-institute)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)

## Its most-cited devices
- K022023: Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500 (2003), cited by 3
- K030691: Fetal Spiral Electrode, Model FSE07000 (2003), cited by 2
- K981260: Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M (1998), cited by 2
- K150573: ebb Complete Tamponade System (2015), cited by 1
- K940681: Clearview Uterine Manipulator (1994), cited by 1
- K974389: Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure Catheter (1998), cited by 1

## Recent decisions
- 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) (Oct 8, 2025)
- K250897: Koala Intrauterine Pressure Catheter (IPC-5000E) (May 22, 2025)
- K223900: babyLance Safety Heelstick (BLM, BLN, BLP) (Feb 24, 2023)
- K153591: ebb Complete Tamponade System (Jan 14, 2016)
- K150573: ebb Complete Tamponade System (Mar 25, 2015)
- K140163: Koala Toco (May 29, 2014)
- K131781: Clearview Total (May 28, 2014)
- K110605: Rom Plus (Nov 23, 2011)

Source page: https://510kreport.com/company/clinical-innovations