510(k) Report

FDA applicant

Bhk Holding

New Port Riche, FL1 decision2000–20000 recalls

FDA records 1 decision for Bhk Holding (New Port Riche, FL) in 2000: 1 510(k) clearance. All are in product code EMX (Balloon, Epistaxis). 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, ear, nose and throat panel, where it files most

How often FDA has decided Bhk Holding’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bhk Holding since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bhk Holding 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?

  • EMXBalloon, Epistaxis1decision

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.

  • K000108Rapid Rhino-Anterior 90MM, Model RR-a 90, Rapid Rhino-Posterior 100MM, Model RR-P 100Bhk Holding · 20001cites it

What has FDA decided for it lately?

  • K000108Rapid Rhino-Anterior 90MM, Model RR-a 90, Rapid Rhino-Posterior 100MM, Model RR-P 100Bhk Holding · 2000

The one decision as Bhk Holding →