Cleared Traditional

EROSA DISPOSABLE HYPODERMIC NEEDLE (K853980) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K853980 · Rose KG · General & Plastic Surgery device
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Oct 1985
Decision
21d
Days
Class 1
Risk

K853980 is an FDA 510(k) clearance for the EROSA DISPOSABLE HYPODERMIC NEEDLE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Rose KG (Washington, US). The FDA issued a Cleared decision on October 18, 1985 after a review of 21 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 Rose KG devices

Submission Details

510(k) Number K853980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1985
Decision Date October 18, 1985
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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 10
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K853980.
MONOJECT BONE MARROW BIOPSY TRAYS
K945109 · Sherwood Medical Co. · Nov 1994
WILSON-COOK LUNG BIOPSY NEEDLE
K897050 · Wilson-Cook Medical, Inc. · Apr 1990
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED
K883014 · Sherwood Medical Co. · Jul 1988
HAWKIN NEEDLE
K851953 · Wilson-Cook Medical, Inc. · May 1985
CHIBA NEEDLE
K851957 · Wilson-Cook Medical, Inc. · May 1985
TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709
K831392 · Travenol Laboratories, S.A. · Jul 1983