510(k) Report

FDA applicant

Medivis, Inc.

New York, NY3 decisions2019–20250 recalls

FDA records 3 decisions for Medivis, Inc. (New York, NY) from 2019 to 2025: 3 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 248 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 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, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Medivis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12024: 12025: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Medivis, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medivis, 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

Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument1decision
  • LLZSystem, Image Processing, Radiological1decision
  • OLOOrthopedic Stereotaxic Instrument1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 248 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K190764SurgicalARMedivis, Inc. · 20193cite it

What has FDA decided for it lately?

  • K231897NeuroAlign softwareMedivis, Inc. · 2025
  • K233725Spine Navigation SystemMedivis, Inc. · 2024
  • K190764SurgicalARMedivis, Inc. · 2019

All 3 as Medivis, Inc. →