Cleared Traditional

K882105 - CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM

K882105 is an FDA 510(k) clearance for CODE #D2020-FINE NEEDLE ASPIRATION BIOP..., manufactured by Dianon Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K882105 · Dianon Systems, Inc. · General & Plastic Surgery device
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Jul 1988
Decision
53d
Days
Class 1
Risk

K882105 is an FDA 510(k) clearance for the CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Dianon Systems, Inc. (Stratford, US). The FDA issued a Cleared decision on July 11, 1988 after a review of 53 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 Dianon Systems, Inc. devices

FDA 510(k) Submission Details - K882105

510(k) Number K882105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received May 19, 1988
Decision Date July 11, 1988
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
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 75
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K882105.
E-Z-EM VACUUM ASPIRATION SYRINGE
K895012 · E-Z-Em, Inc. · Dec 1989
THORACENTISIS KIT
K894326 · Mill-Rose Laboratory · Jul 1989
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED
K883014 · Sherwood Medical Co. · Jul 1988
NOVO VIVO MODEL #17140 AND #17135
K880377 · Genesis Industries, Inc. · Apr 1988
MEDSURG CHIBA PTC NEEDLE
K870893 · Medsurg Industries, Inc. · Mar 1987
NAMIC CHIBA ASPIRATION BIOPSY NEEDLE
K864800 · North American Instrument Corp. · Feb 1987