FDA applicant
Innovative Health, LLC
FDA records 51 decisions for Innovative Health, LLC (Scottsdale, AZ) from 2016 to 2026: 51 510(k) clearances. Most are in product codes NLH (Catheter, Recording, Electrode, Reprocessed) and OWQ (Reprocessed Intravascular Ultrasound Catheter). Since 2016 its 510(k)s took a median of 141 days from receipt to decision, against 133 for FDA’s reviews in the same codes and years. Its devices cite 78 predicates, 11 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Innovative Health”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Innovative Health, LLC’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Innovative Health, LLC’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