Cleared Traditional

K942828 - MAKAR FULL AND HALF FACE SHIELD (FDA 510(k) Clearance)

Class I General Hospital device.

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.

View all Instrument Makar, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 128d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.