Cleared Traditional

K853980 - EROSA DISPOSABLE HYPODERMIC NEEDLE

K853980 is an FDA 510(k) clearance for EROSA DISPOSABLE HYPODERMIC NEEDLE, manufactured by Rose KG. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 21-day FDA review.

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

FDA 510(k) Submission Details - K853980

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.

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 K853980.
TBI NEEDLE
K860582 · Hobbs Medical, Inc. · Mar 1986
ANGIOMED FINE NEEDLES AND NEEDLE SET
K855141 · Angiomed U.S., Inc. · Jan 1986
NEEDLE W/STYLET FOR IMPLANTATION
K854238 · Microvasive · Nov 1985
MANAN TROCAR STYLE BIOPSY NEEDLE
K852426 · Manan Manufacturing Co., Inc. · Jun 1985
MANAN SPINAL NEEDLE
K852427 · Manan Manufacturing Co., Inc. · Jun 1985
HAWKIN NEEDLE
K851953 · Wilson-Cook Medical, Inc. · May 1985