FDA applicant

Deep Breeze, Ltd.

Washington, DC3 decisions2007–20100 recalls

FDA records 3 decisions for Deep Breeze, Ltd. (Washington, DC) from 2007 to 2010: 3 510(k) clearances. All are in product code OCR (Lung Sound Monitor). Its devices cite 5 predicates, 3 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2010

2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Deep Breeze, Ltd.’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 “Deep”

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

Deep Blue Medical Advances, Inc. 4 Deep Breathe, Inc. 2 Deep Trading Corp. 1 Deep Reasoning Ai, Inc. 1

Deep Breeze, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Deep”