510(k) Report

FDA applicant

Bright Medical Instruments

Boca Raton, FL1 decision1999–19990 recalls

FDA records 1 decision for Bright Medical Instruments (Boca Raton, FL) in 1999: 1 510(k) clearance. All are in product code GZT (Retractor, Self-Retaining, For Neurosurgery). 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 Bright Medical Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bright Medical Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bright Medical Instruments 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?

  • GZTRetractor, Self-Retaining, For Neurosurgery1decision

Who builds on its devices?

Later devices cite its devices 6 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.

  • K992898The Bright Medical Dilation Retractor SystemBright Medical Instruments · 19996cite it

What has FDA decided for it lately?

  • K992898The Bright Medical Dilation Retractor SystemBright Medical Instruments · 1999

The one decision as Bright Medical Instruments →

Other applicant names beginning “Bright”

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

Bright Element Sdn Bhd 4Bright Spine 3Bright Uro, Inc. 2Bright Rubber Industries Private, Ltd. 1Bright Horizon Ent. 1