FDA applicant
Clinical Innovations, Inc.
FDA records 18 decisions for Clinical Innovations, Inc. (Murray, UT) from 1994 to 2025: 18 510(k) clearances. Most are in product codes HFN (Transducer, Pressure, Intrauterine) and OQY (Intrauterine Tamponade Balloon). Its devices cite 26 predicates, 4 of them its own earlier devices. 9 recalls are linked to its devices.
FDA’s records also spell it “Clinical Innovations, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Clinical Innovations, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Clinical Innovations, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report