Cleared Traditional

K895012 - E-Z-EM VACUUM ASPIRATION SYRINGE

K895012 is the FDA 510(k) clearance for E-Z-EM VACUUM ASPIRATION SYRINGE by E-Z-Em, Inc.. It is a Class 1 General & Plastic Surgery device (product code GAA) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K895012 · E-Z-Em, Inc. · General & Plastic Surgery device
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Dec 1989
Decision
141d
Days
Class 1
Risk

K895012 is an FDA 510(k) clearance for the E-Z-EM VACUUM ASPIRATION SYRINGE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on December 27, 1989 after a review of 141 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K895012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date December 27, 1989
Days to Decision 141 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAA Needle, Aspiration And Injection, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GAA Needle, Aspiration And Injection, Disposable

All 38
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K895012.
BONE MARROW BIOPSY TRAY
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MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.
K896019 · Dlp, Inc. · Jan 1990
THORACENTISIS KIT
K894326 · Mill-Rose Laboratory · Jul 1989
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED
K883014 · Sherwood Medical Co. · Jul 1988
MEDSURG CHIBA PTC NEEDLE
K870893 · Medsurg Industries, Inc. · Mar 1987