510(k) Report

FDA applicant

Covalontechnologies, Inc.

Largo, FL6 decisions2005–20170 recalls

FDA records 6 decisions for Covalontechnologies, Inc. (Largo, FL) from 2005 to 2017: 6 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 10 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2017

2012: 22015: 12017: 1
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Covalontechnologies, 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, Drug3decisions
  • KKXDrape, Surgical, Antimicrobial1decision
  • KGNWound Dressing With Animal-Derived Material (S)1decision
  • EZLCatheter, Retention Type, Balloon1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 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.

  • K050177Colactive Collagen Wound DressingCovalontechnologies, Inc. · 20053cite it
  • K121819Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc. · 20122cite it
  • K043296Colactive AG Collagen with Silver Antimicrobial DressingCovalontechnologies, Inc. · 20052cite it

What has FDA decided for it lately?

  • K163556MediClear PreOpCovalontechnologies, Inc. · 2017
  • K150550SilverCoat Silicone Foley CatheterCovalontechnologies, Inc. · 2015
  • K121819Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc. · 2012
  • K112549IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc. · 2012
  • K043296Colactive AG Collagen with Silver Antimicrobial DressingCovalontechnologies, Inc. · 2005
  • K050177Colactive Collagen Wound DressingCovalontechnologies, Inc. · 2005

All 6 as Covalontechnologies, Inc. →