510(k) Report

FDA applicant

Navinetics, Inc.

Rochester, MN2 decisions2021–20231 recall

FDA records 2 decisions for Navinetics, Inc. (Rochester, MN) from 2021 to 2023: 2 510(k) clearances. All are in product code HAW (Neurological Stereotaxic Instrument). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 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 Navinetics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 12023: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2021high 1 (2024) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Navinetics, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Navinetics, Inc.’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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Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210700NaviNetics D1 Stereotactic SystemNavinetics, Inc. · 20211cites it

What has FDA decided for it lately?

  • K231392NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc. · 20231 recall
  • K210700NaviNetics D1 Stereotactic SystemNavinetics, Inc. · 2021

All 2 as Navinetics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K231392NaviNetics Skull Anchor Key and Drill Kit, REF NN1215Feb 26, 2024Class II