Cleared Traditional

K894326 - THORACENTISIS KIT

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

K894326 · Mill-Rose Laboratory · General & Plastic Surgery device
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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.

FDA 510(k) Submission Details - K894326

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.

GAA Device Classification - Class 1, General Controls

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 105
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K894326.
16 GA X 10 BULLET POINT NEEDLE
K894873 · R. J. Doyle, Inc. · Sep 1989
14 INCH BULLET POINT NEEDLE
K894874 · R. J. Doyle, Inc. · Sep 1989
20GA X 7-1/2 THREADING BULLET POINT NEEDLE
K894875 · R. J. Doyle, Inc. · Sep 1989
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED
K883014 · Sherwood Medical Co. · Jul 1988
CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM
K882105 · Dianon Systems, Inc. · Jul 1988
NOVO VIVO MODEL #17140 AND #17135
K880377 · Genesis Industries, Inc. · Apr 1988
K894326 · THORACENTISIS KIT
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