510(k) Report

FDA applicant

Resmed Pty Ltd (Registration Number: 3004604967)

Bella Vista, AU3 decisions2023–20240 recalls

FDA records 3 decisions for Resmed Pty Ltd (Registration Number: 3004604967) (Bella Vista, AU) from 2023 to 2024: 3 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Since 2016 its 510(k)s took a median of 239 days from receipt to decision, against 204 for FDA’s reviews in the same codes and years. Its devices cite 3 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, anesthesiology panel, where it files most

How often FDA has decided Resmed Pty Ltd (Registration Number: 3004604967)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 22024: 1
2023high 2 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Resmed Pty Ltd (Registration Number: 3004604967) by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Resmed Pty Ltd (Registration Number…’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?

  • BZDVentilator, Non-Continuous (Respirator)3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 239 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 204 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 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.

  • K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemResmed Pty Ltd (Registration Number: 3004604967) · 20241cites it

What has FDA decided for it lately?

  • K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemResmed Pty Ltd (Registration Number: 3004604967) · 2024
  • K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967) · 2023
  • K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967) · 2023

All 3 as Resmed Pty Ltd (Registration Number: 3004604967) →

Other applicant names beginning “Resmed”

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

Resmed, Ltd. 126Resmed Germany, Inc. 8