510(k) Report

FDA applicant

Dorsavi, Ltd.

East Melbourne, AU2 decisions2015–20170 recalls

FDA records 2 decisions for Dorsavi, Ltd. (East Melbourne, AU) from 2015 to 2017: 2 510(k) clearances. All are in product code IKN (Electromyograph, Diagnostic). Its devices cite 1 predicate, 1 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2017

2015: 12017: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Dorsavi, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dorsavi, 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?

  • IKNElectromyograph, Diagnostic2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142494ViMoveDorsavi, Ltd. · 20151cites it

What has FDA decided for it lately?

All 2 as Dorsavi, Ltd. →