Cleared Traditional

K942828 - MAKAR FULL AND HALF FACE SHIELD

K942828 is an FDA 510(k) clearance for MAKAR FULL AND HALF FACE SHIELD, manufactured by Instrument Makar, Inc.. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K942828 · Instrument Makar, Inc. · General Hospital
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Feb 1995
Decision
254d
Days
Class 1
Risk

K942828 is an FDA 510(k) clearance for the MAKAR FULL AND HALF FACE SHIELD. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Instrument Makar, Inc. (Okemos, US). The FDA issued a Cleared decision on February 23, 1995 after a review of 254 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K942828

510(k) Number K942828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1994
Decision Date February 23, 1995
Days to Decision 254 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
125d slower than avg
Panel avg: 129d · This submission: 254d
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 55
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K942828.
INCASE EXTENSIBLE BAG--NON-STERILE
K951420 · Alpha Surgical, Inc. · Jun 1995
CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER
K944763 · Wells Lamont Corp. · Apr 1995
OP-D-OP II
K945098 · Op-D-Op Visor Shields, Inc. · Feb 1995
MONOGARD FACE SHIELD
K943809 · White Knight Healthcare · Nov 1994
SHOE COVER
K940226 · Derekduck Industries Corp. · Sep 1994
BOUFFANT CAP
K940228 · Derekduck Industries Corp. · Sep 1994
K942828 · MAKAR FULL AND HALF FACE SHIELD
Download PDF Instrument Makar, Inc.