510(k) Report

FDA applicant

Exploramed Nc1, Inc.

Mountain View, CA1 decision2005–20050 recalls

FDA records 1 decision for Exploramed Nc1, Inc. (Mountain View, CA) in 2005: 1 510(k) clearance. All are in product code LRC (Instrument, Ent Manual Surgical). 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 Exploramed Nc1, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Exploramed Nc1, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Exploramed Nc1, 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?

  • LRCInstrument, Ent Manual Surgical1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K043527Relieva Sinus Balloon Dilation CatheterExploramed Nc1, Inc. · 20054cite it

What has FDA decided for it lately?

  • K043527Relieva Sinus Balloon Dilation CatheterExploramed Nc1, Inc. · 2005

The one decision as Exploramed Nc1, Inc. →

Other applicant names beginning “Exploramed”

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

Exploramed Nc7, Inc. 2