510(k) Report

FDA applicant

Compumedics Limited

Abbotsford, AU9 decisions2000–20250 recalls

FDA records 9 decisions for Compumedics Limited (Abbotsford, AU) from 2000 to 2025: 9 510(k) clearances. Most are in product codes MNR (Ventilatory Effort Recorder) and OLV (Standard Polysomnograph With…). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 165 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 5 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 Compumedics Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2008: 12010: 12020: 12023: 22025: 2
2007high 2 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Compumedics Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MNRVentilatory Effort Recorder4decisions
  • OLVStandard Polysomnograph With Electroencephalograph2decisions
  • GWQFull-Montage Standard Electroencephalograph2decisions
  • OLYMagnetoencephalograph1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 165 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 5 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.

  • K003175Compumedics Siesta SystemCompumedics Limited · 20006cite it
  • K021176Compumedics Somte SystemCompumedics Limited · 20034cite it
  • K072201Compumedics Somte PSG Recording SystemCompumedics Limited · 20083cite it
  • K093223Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited · 20101cites it
  • K231546SomfitCompumedics Limited · 20231cites it

What has FDA decided for it lately?

  • K252383Somfit DCompumedics Limited · 2025
  • K242447Falcon HSTCompumedics Limited · 2025
  • K231546SomfitCompumedics Limited · 2023
  • K230073OktiCompumedics Limited · 2023
  • K191785Orion LifeSpan MEGCompumedics Limited · 2020
  • K093223Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited · 2010
  • K072201Compumedics Somte PSG Recording SystemCompumedics Limited · 2008
  • K021176Compumedics Somte SystemCompumedics Limited · 2003

All 9 as Compumedics Limited →

Other applicant names beginning “Compumedics”

FDA records each applicant name separately; these may or may not be the same firm.

Compumedics USA, Ltd. 3Compumedics Ptd, Ltd. 1Compumedics Neuro Science Pty, Ltd. 1Compumedics Germany Gmgh 1