510(k) Report

FDA applicant

Anacapa Technologies, Inc.

San Dimas, CA2 decisions2006–20080 recalls

FDA records 2 decisions for Anacapa Technologies, Inc. (San Dimas, CA) from 2006 to 2008: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 4 predicates, 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 Anacapa Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • FRODressing, Wound, Drug2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 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.

  • K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 200817cite it
  • K062212Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SAnacapa Technologies, Inc. · 20068cite it

What has FDA decided for it lately?

  • K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008
  • K062212Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SAnacapa Technologies, Inc. · 2006

All 2 as Anacapa Technologies, Inc. →