510(k) Report

FDA applicant

Hammer-Plane, Inc.

Simi Valley, CA2 decisions1993–19950 recalls

FDA records 2 decisions for Hammer-Plane, Inc. (Simi Valley, CA) from 1993 to 1995: 2 510(k) clearances. Most are in product codes CBH (Device, Fixation, Tracheal Tube) and CBT (Arterial Blood Sampling Kit). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Hammer-Plane, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hammer-Plane, 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?

  • CBHDevice, Fixation, Tracheal Tube1decision
  • CBTArterial Blood Sampling Kit1decision

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.

  • K950098Needle Safety CoverHammer-Plane, Inc. · 19951cites it

What has FDA decided for it lately?

  • K950098Needle Safety CoverHammer-Plane, Inc. · 1995
  • K933781Anti-Disconnection MechanismHammer-Plane, Inc. · 1993

All 2 as Hammer-Plane, Inc. →