510(k) Report

FDA applicant

Dinkler Surgical Devices, Inc.

Dayton, OH2 decisions2008–20090 recalls

FDA records 2 decisions for Dinkler Surgical Devices, Inc. (Dayton, OH) from 2008 to 2009: 2 510(k) clearances. All are in product code HBL (Holder, Head, Neurosurgical (Skull Clamp)). Its devices cite 3 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, neurology panel, where it files most

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

FDA decisions per year

1in 2009

2008: 12009: 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Dinkler Surgical Devices, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HBLHolder, Head, Neurosurgical (Skull Clamp)2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K073163Limited Artifact Skull Pin, Model 0107Dinkler Surgical Devices, Inc. · 20081cites it

What has FDA decided for it lately?

  • K090695Dinkler Surgical Skull Clamp, Model 0308Dinkler Surgical Devices, Inc. · 2009
  • K073163Limited Artifact Skull Pin, Model 0107Dinkler Surgical Devices, Inc. · 2008

All 2 as Dinkler Surgical Devices, Inc. →