Cleared Traditional

K942022 - FACE-IT SHIELD

K942022 is an FDA 510(k) clearance for FACE-IT SHIELD, manufactured by Onyx Medical Corp.. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K942022 · Onyx Medical Corp. · General Hospital
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Jul 1994
Decision
73d
Days
Class 1
Risk

K942022 is an FDA 510(k) clearance for the FACE-IT SHIELD. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Onyx Medical Corp. (Sausalito, US). The FDA issued a Cleared decision on July 8, 1994 after a review of 73 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 Onyx Medical Corp. devices

FDA 510(k) Submission Details - K942022

510(k) Number K942022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1994
Decision Date July 08, 1994
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
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 9
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K942022.
DISPOSABLE APRON
K964364 · Instrument Makar, Inc. · Feb 1997
DEPUY DISPOSABLE FILTER/HOOD
K961791 · Depuy, Inc. · Aug 1996
MAKAR FULL AND HALF FACE SHIELD
K942828 · Instrument Makar, Inc. · Feb 1995
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