510(k) Report

FDA applicant

Aubrey, Inc.

Carlsbad, CA2 decisions2009–20100 recalls

FDA records 2 decisions for Aubrey, Inc. (Carlsbad, CA) from 2009 to 2010: 2 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 1 predicate, 1 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

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

FDA decisions per year

1in 2010

2009: 12010: 1
2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Aubrey, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aubrey, 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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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision
  • KGNWound Dressing With Animal-Derived Material (S)1decision

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082869Awbat-S, Awbat-D, Awbat-MAubrey, Inc. · 20092cite it
  • K091863Awbat-S Plus, Awbat-D Plus, Awbat-M PlusAubrey, Inc. · 20101cites it

What has FDA decided for it lately?

  • K091863Awbat-S Plus, Awbat-D Plus, Awbat-M PlusAubrey, Inc. · 2010
  • K082869Awbat-S, Awbat-D, Awbat-MAubrey, Inc. · 2009

All 2 as Aubrey, Inc. →