Cleared Traditional

K964364 - DISPOSABLE APRON

K964364 is an FDA 510(k) clearance for DISPOSABLE APRON, 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 116-day FDA review.

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

FDA 510(k) Submission Details - K964364

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 129d · This submission: 116d
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 15
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K964364.
STRYKER T4 HYTREL (R) TOGAS
K011755 · Stryker Corp. · Jun 2001
NURSES BOUFFANT CAP
K965237 · Copioumed Intl., Inc. · Aug 1997
FAR-EAST BOUFFANT CAPS
K970988 · Far East Science & Technology Development Co., Ltd. · Jul 1997
DEPUY DISPOSABLE FILTER/HOOD
K961791 · Depuy, Inc. · Aug 1996
AMMI MAGNI-GUARD
K961454 · American Medical Mfg., Inc. · Jul 1996
SLOAN STA-DRI PANT PROTECTOR
K945302 · Sloan Corp. · Mar 1996