Cleared Traditional

SHADOW MEDAL LOCATOR (K953277) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953277 · Fatswith Intl., Inc. · Ophthalmic device
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Apr 1996
Decision
263d
Days
Class 2
Risk

K953277 is an FDA 510(k) clearance for the SHADOW MEDAL LOCATOR. Classified as Locator, Metal, Electronic (product code HPM), Class II - Special Controls.

Submitted by Fatswith Intl., Inc. (Vancouver, Bc,, CA). The FDA issued a Cleared decision on April 1, 1996 after a review of 263 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4400 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Fatswith Intl., Inc. devices

Submission Details

510(k) Number K953277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1995
Decision Date April 01, 1996
Days to Decision 263 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 110d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HPM Locator, Metal, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.