510(k) Report

FDA applicant

American Biotech Labs

Washington, DC2 decisions2009–20090 recalls

FDA records 2 decisions for American Biotech Labs (Washington, DC) in 2009: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 8 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 American Biotech Labs’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009: 2
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — American Biotech Labs by year, 2009–2026Sources: 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 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K082333Asap Wound Dressing GelAmerican Biotech Labs · 20093cite it
  • K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 20092cite it

What has FDA decided for it lately?

  • K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009
  • K082333Asap Wound Dressing GelAmerican Biotech Labs · 2009

All 2 as American Biotech Labs →