510(k) Report

FDA applicant

Mountain Shades, Inc.

Vail, CO3 decisions1994–19940 recalls

FDA records 3 decisions for Mountain Shades, Inc. (Vail, CO) in 1994: 3 510(k) clearances. All are in product code HQY (Sunglasses (Non-Prescription Including…). 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, ophthalmic panel, where it files most

How often FDA has decided Mountain Shades, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mountain Shades, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mountain Shades, 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?

  • HQYSunglasses (Non-Prescription Including Photosensitive)3decisions

What has FDA decided for it lately?

  • K940831Ski Vector Non-Prescription SunglassesMountain Shades, Inc. · 1994
  • K940740Ski Vector Non Precription SunglassesMountain Shades, Inc. · 1994
  • K940741Mountain Shades -Nonprescription SunglassesMountain Shades, Inc. · 1994

All 3 as Mountain Shades, Inc. →

Other applicant names beginning “Mountain”

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

Mountain Medical Equipment, Inc. 20Mountain Medico, Inc. 2Mountain View Medical 2Mountain Precision Mfg. Ltd. Co. 1