Cleared Traditional

K945351 - SHIELD, EYE, OPHTHALMIC

K945351 is an FDA 510(k) clearance for SHIELD, manufactured by Taiwan Eva Industrial Co., Inc.. The device is a Class 1 Ophthalmic device with product code HOY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K945351 · Taiwan Eva Industrial Co., Inc. · Ophthalmic device
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Dec 1994
Decision
90d
Days
Class 1
Risk

K945351 is an FDA 510(k) clearance for the SHIELD, EYE, OPHTHALMIC. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by Taiwan Eva Industrial Co., Inc. (Kaohsiung, TW). The FDA issued a Cleared decision on December 13, 1994 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4750 - 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 Taiwan Eva Industrial Co., Inc. devices

FDA 510(k) Submission Details - K945351

510(k) Number K945351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1994
Decision Date December 13, 1994
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

HOY Device Classification - Class 1, General Controls

Product Code HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

All 16
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K945351.
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
K132042 · X6d, Ltd. · Apr 2014
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
K050856 · Ophthocare , Ltd. · May 2005
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
K971465 · National Healthcare Mfg. Corp. · Jun 1997
SHAIDS PROTECTIVE GLASSES
K930347 · Depuy, Inc. · Apr 1994
MODIFICATION OF SURGICAL EYESHIELD MASK
K934085 · American Threshold Industries, Inc. · Nov 1993
EYE BUBBLE
K912367 · Aaron Medical Industries · Oct 1991