FDA applicant

Resmed Germany, Inc.

Poway, CA8 decisions2006–20151 recall

FDA records 8 decisions for Resmed Germany, Inc. (Poway, CA) from 2006 to 2015: 8 510(k) clearances. Most are in product codes MNR (Ventilatory Effort Recorder) and MNT (Continuous, Minimal Ventilatory Support…). Its devices cite 14 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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 Germany, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 2 (2013) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2019

2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Resmed Germany, 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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Other applicant names beginning “Resmed”

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

Resmed, Ltd. 126 Resmed Pty Ltd (Registration Number: 3004604967) 3

Resmed Germany, Inc.

Which product codes does it file in?

Whose devices does it build on?

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Other applicant names beginning “Resmed”