FDA applicant

Blue Focus

Lawrenceville, GA1 decision2013–20130 recalls

FDA records 1 decision for Blue Focus (Lawrenceville, GA) in 2013: 1 510(k) clearance. All are in product code ERA (Otoscope). Its devices cite 2 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, ear, nose and throat panel, where it files most

How often FDA has decided Blue Focus’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Blue Focus by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Blue Focus’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 “Blue”

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

Blue Belt Technologies, Inc. 22 Blue Sky Bio, LLC 21 Blue Ridge Media Co. 11 Blue Ortho 9 Blue Sky Medical Group Incorporated 4 Blue Planet Industries, Inc. 3 Blue Torch Medical Technologies 2 Blue Sail Medical Co.,Ltd 2 Blue X Imaging Srl 2 Blue Spark Technologies, Inc. 2 Blue & Red Corp. 1 Blue Gem Sunglasses, Inc. 1

Blue Focus

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Blue”