510(k) Report

FDA applicant

IceCure Medical, Ltd.

Caesarea, IL5 decisions2010–20261 recall

FDA records 5 decisions for IceCure Medical, Ltd. (Caesarea, IL) from 2010 to 2026: 4 510(k) clearances and 1 De Novo grant. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and QXW (Cryoablation Device For Local Treatment Of…). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Icecure Medical”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2025

2010: 12019: 12024: 12025: 12026 (partial year): 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2010high 1 (2019) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — IceCure Medical, Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like IceCure Medical, Ltd.’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?

  • GEHUnit, Cryosurgical, Accessories4decisions
  • QXWCryoablation Device For Local Treatment Of Low-Risk Breast Cancer1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 115 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K102360Icesence 3IceCure Medical, Ltd. · 20102cite it
  • K240892XSense Cryoablation System with CryoprobesIceCure Medical, Ltd. · 20242cite it
  • K183213IceSense 3, ProSense, MultiSenseIceCure Medical, Ltd. · 20191cites it

What has FDA decided for it lately?

  • K260377XSense Cryoablation System with CryoProbesIceCure Medical, Ltd. · 2026
  • DEN220077ProSense™ SystemIcecure Medical · 2025
  • K240892XSense Cryoablation System with CryoprobesIceCure Medical, Ltd. · 2024
  • K183213IceSense 3, ProSense, MultiSenseIceCure Medical, Ltd. · 2019
  • K102360Icesence 3IceCure Medical, Ltd. · 20101 recall

All 4 as IceCure Medical, Ltd. →The one decision as Icecure Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K102360IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue…Sep 16, 2019Class II