510(k) Report

FDA applicant

Neuwave Medical, Inc.

Madision, WI15 decisions2010–20240 recalls

FDA records 15 decisions for Neuwave Medical, Inc. (Madision, WI) from 2010 to 2024: 15 510(k) clearances. Most are in product codes NEY (System, Ablation, Microwave And Accessories) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 121 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 25 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2024

2010: 12012: 22013: 12015: 12016: 22017: 22018: 12019: 12020: 12022: 12023: 12024: 1
2010high 2 (2012) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

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

Planning a device like Neuwave Medical, 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?

  • NEYSystem, Ablation, Microwave And Accessories10decisions
  • JAKSystem, X-Ray, Tomography, Computed4decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 121 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 121 days; 3 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 33 predicates; 25 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 29 times; 25 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.

  • K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 20106cite it
  • K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 20125cite it
  • K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 20124cite it
  • K130399Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc. · 20133cite it
  • K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 20202cite it
  • K150313Ablation ConfirmationNeuwave Medical, Inc. · 20152cite it

What has FDA decided for it lately?

  • K232227Ablate-IQNeuwave Medical, Inc. · 2024
  • K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2023
  • K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2022
  • K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2020
  • K192427Ablation ConfirmationNeuwave Medical, Inc. · 2019
  • K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. · 2018
  • K171022Ablation ConfirmationNeuwave Medical, Inc. · 2017
  • K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc. · 2017

All 15 as Neuwave Medical, Inc. →