Cleared Traditional

K894326 - THORACENTISIS KIT

K894326 is the FDA 510(k) clearance for THORACENTISIS KIT by Mill-Rose Laboratory. It is a Class 1 General & Plastic Surgery device (product code GAA) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K894326 · Mill-Rose Laboratory · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1989
Decision
10d
Days
Class 1
Risk

K894326 is an FDA 510(k) clearance for the THORACENTISIS KIT. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on July 24, 1989 after a review of 10 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mill-Rose Laboratory devices

Submission Details

510(k) Number K894326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1989
Decision Date July 24, 1989
Days to Decision 10 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
105d faster than avg
Panel avg: 115d · This submission: 10d
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 32
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K894326.
WILSON-COOK LUNG BIOPSY NEEDLE
K897050 · Wilson-Cook Medical, Inc. · Apr 1990
MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.
K896019 · Dlp, Inc. · Jan 1990
E-Z-EM VACUUM ASPIRATION SYRINGE
K895012 · E-Z-Em, Inc. · Dec 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
HAWKIN NEEDLE
K851953 · Wilson-Cook Medical, Inc. · May 1985