510(k) Report

FDA applicant

Immersivetouch

Chicago, IL4 decisions2014–20231 recall

FDA records 4 decisions for Immersivetouch (Chicago, IL) from 2014 to 2023: 4 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and DZJ (Driver, Wire, And Bone Drill, Manual). Since 2016 its 510(k)s took a median of 259 days from receipt to decision, against 157 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Immersivetouch, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

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

FDA decisions per year

1in 2023

2014: 12020: 12021: 12023: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2014high 1 (2020) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Immersivetouch by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Immersivetouch’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?

  • LLZSystem, Image Processing, Radiological3decisions
  • DZJDriver, Wire, And Bone Drill, Manual1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 259 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 157 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K230249IkshanaImmersivetouch · 20231cites it
  • K210726ImmersiveTouchImmersivetouch, Inc. · 20211cites it

What has FDA decided for it lately?

  • K230249IkshanaImmersivetouch · 2023
  • K210726ImmersiveTouchImmersivetouch, Inc. · 2021
  • K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch · 2020
  • K140860ImmersiveTouch3 and MicrovisTouchImmersivetouch · 20141 recall

All 3 as Immersivetouch →The one decision as Immersivetouch, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K140860ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as…Apr 3, 2020Class III