FDA applicant

Zephyr Sleep Technologies

Calgary, CA7 decisions2012–20200 recalls

FDA records 7 decisions for Zephyr Sleep Technologies (Calgary, CA) from 2012 to 2020: 6 510(k) clearances and 1 De Novo grant. Most are in product codes MNR (Ventilatory Effort Recorder) and LRK (Device, Anti-Snoring). Since 2016 its 510(k)s took a median of 129 days from receipt to decision, against 192 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Zephyr Sleep Technologies, Inc.”.

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 Zephyr Sleep Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012high 2 (2018) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Zephyr Sleep Technologies by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zephyr Sleep Technologies’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Zephyr”

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

Zephyr Technology Corporation 4

Zephyr Sleep Technologies

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Zephyr”