FDA applicant
Phasor Health, LLC
FDA records 5 decisions for Phasor Health, LLC (Houston, TX) in 2025: 5 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and HBE (Drills, Burrs, Trephines & Accessories…). Since 2016 its 510(k)s took a median of 130 days from receipt to decision, against 209 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Phasor Health, LLC’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Phasor Health, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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