Cleared Traditional

K911742 - OP-D-OP VISOR SHIELDS

K911742 is an FDA 510(k) clearance for OP-D-OP VISOR SHIELDS, manufactured by Op-D-Op, Inc.. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K911742 · Op-D-Op, Inc. · General Hospital
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Jun 1991
Decision
50d
Days
Class 1
Risk

K911742 is an FDA 510(k) clearance for the OP-D-OP VISOR SHIELDS. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Op-D-Op, Inc. (Roseville, US). The FDA issued a Cleared decision on June 7, 1991 after a review of 50 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 Op-D-Op, Inc. devices

FDA 510(k) Submission Details - K911742

510(k) Number K911742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1991
Decision Date June 07, 1991
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

LYU Device Classification - Class 1, General Controls

Product Code LYU Accessory, Surgical Apparel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
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 - LYU Accessory, Surgical Apparel

All 16
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K911742.
PROCEL(TM) DERMALINER GLOVE
K931094 · W.L. Gore & Associates, Inc. · Feb 1994
ULTRATUFF CUT RESISTANT GLOVE LINER
K925628 · Baxter Healthcare Corp · Jul 1993
GUARDALL SHIELD
K915415 · Anago, Inc. · Oct 1992
CUT RESISTANT GLOVE LINER
K902633 · Biomet, Inc. · Jul 1990
STERILE HAND COVER
K894064 · Sage Products, Inc. · Aug 1989