Cleared Traditional

INTEC EXTENDED EYE SHIELD WITH MASK (K946343) - FDA 510(k) Clearance

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

K946343 · Intec Industries, Inc. · General Hospital
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Mar 1995
Decision
82d
Days
Class 2
Risk

K946343 is an FDA 510(k) clearance for the INTEC EXTENDED EYE SHIELD WITH MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Intec Industries, Inc. (Birmingham, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 82 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intec Industries, Inc. devices

Submission Details

510(k) Number K946343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1994
Decision Date March 22, 1995
Days to Decision 82 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 129d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 401
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K946343.
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
K964114 · Depuy, Inc. · May 1997
MEDLINE ADMISSION KITS
K965107 · Medline Industries, Inc. · Mar 1997
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · 3M Company · May 1996
3M SURGICAL MASK WITH FACE SHEILD
K940707 · 3M Company · May 1994
SURGICAL APPAREL
K914832 · W.L. Gore & Associates, Inc. · Feb 1992
TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK
K910110 · 3M Company · Mar 1991