510(k) Report

FDA applicant

Navbit Pty, Ltd.

Crows Nest, AU2 decisions2020–20240 recalls

FDA records 2 decisions for Navbit Pty, Ltd. (Crows Nest, AU) from 2020 to 2024: 2 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and LLZ (System, Image Processing, Radiological). Its devices cite 2 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 Navbit Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12024: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Navbit Pty, Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Navbit Pty, Ltd.’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?

  • OLOOrthopedic Stereotaxic Instrument1decision
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd. · 20201cites it

What has FDA decided for it lately?

  • K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd. · 2024
  • K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd. · 2020

All 2 as Navbit Pty, Ltd. →