Cleared Traditional

K953277 - SHADOW MEDAL LOCATOR

K953277 is an FDA 510(k) clearance for SHADOW MEDAL LOCATOR, manufactured by Fatswith Intl., Inc.. The device is a Class 2 Ophthalmic device with product code HPM cleared through the Traditional 510(k) pathway after a 263-day FDA review.

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

FDA 510(k) Submission Details - K953277

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
Combination Product No
PCCP Authorized No
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.

HPM Device Classification - Class 2, Special Controls

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.