510(k) Report

FDA applicant

Gebauer Medizintechnik GmbH

Lexington, MA2 decisions2004–20090 recalls

FDA records 2 decisions for Gebauer Medizintechnik GmbH (Lexington, MA) from 2004 to 2009: 2 510(k) clearances. All are in product code HNO (Keratome, Ac-Powered). 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

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Gebauer Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gebauer Medizintechnik GmbH 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?

  • HNOKeratome, Ac-Powered2decisions

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 2 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.

  • K041206Epitome SystemGebauer Medizintechnik GmbH · 20042cite it

What has FDA decided for it lately?

  • K072102Epivision SL SystemGebauer Medizintechnik GmbH · 2009
  • K041206Epitome SystemGebauer Medizintechnik GmbH · 2004

All 2 as Gebauer Medizintechnik GmbH →

Other applicant names beginning “Gebauer”

FDA records each applicant name separately; these may or may not be the same firm.

Gebauer Co. 11