Cleared Traditional

K894874 - 14 INCH BULLET POINT NEEDLE

K894874 is the FDA 510(k) clearance for 14 INCH BULLET POINT NEEDLE by R. J. Doyle, Inc.. It is a Class 1 General & Plastic Surgery device (product code GAA) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K894874 · R. J. Doyle, Inc. · General & Plastic Surgery device
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Sep 1989
Decision
52d
Days
Class 1
Risk

K894874 is an FDA 510(k) clearance for the 14 INCH BULLET POINT NEEDLE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by R. J. Doyle, Inc. (Spirit Lake, US). The FDA issued a Cleared decision on September 22, 1989 after a review of 52 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 R. J. Doyle, Inc. devices

Submission Details

510(k) Number K894874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date September 22, 1989
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
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 11
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