FDA applicant

Blue Sky Medical Group Incorporated

Carlsbad, CA4 decisions2004–20073 recalls

FDA records 4 decisions for Blue Sky Medical Group Incorporated (Carlsbad, CA) from 2004 to 2007: 4 510(k) clearances. All are in product code OMP (Negative Pressure Wound Therapy Powered…). Its devices cite 7 predicates, 5 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Blue Sky Medical Group Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Blue Sky Medical Group Incorporated by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Blue Sky Medical Group Incorporated’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 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 Focus 1 Blue Gem Sunglasses, Inc. 1

Blue Sky Medical Group Incorporated

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Blue”