Cleared Traditional

K964364 - DISPOSABLE APRON (FDA 510(k) Clearance)

Class I General Hospital device.

K964364 · Instrument Makar, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
116d
Days
Class 1
Risk

K964364 is an FDA 510(k) clearance for the DISPOSABLE APRON. 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 25, 1997 after a review of 116 days - within the typical 510(k) review window.

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 K964364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date February 25, 1997
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 128d · This submission: 116d
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.