Cleared Traditional

K842699 - ISLAM BONE MARROW ASPIRATION NEEDLES

K842699 is an FDA 510(k) clearance for ISLAM BONE MARROW ASPIRATION NEEDLES, manufactured by Downs Surgical , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K842699 · Downs Surgical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
22d
Days
Class 1
Risk

K842699 is an FDA 510(k) clearance for the ISLAM BONE MARROW ASPIRATION NEEDLES. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 22 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 Downs Surgical , Ltd. devices

FDA 510(k) Submission Details - K842699

510(k) Number K842699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1984
Decision Date August 02, 1984
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
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 41
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K842699.
HAWKIN NEEDLE
K851953 · Wilson-Cook Medical, Inc. · May 1985
CHIBA NEEDLE
K851957 · Wilson-Cook Medical, Inc. · May 1985
GILL'S IRRIGATOR/ASPIRATOR NEEDLE
K843925 · Concept, Inc. · Nov 1984
INTRADISCAL THERAPY NEEDLE 18 GAUGE
K840922 · Dlp, Inc. · Apr 1984
TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709
K831392 · Travenol Laboratories, S.A. · Jul 1983
STERILE, DISPOSABLE, HYPODERMIC NEEDLES
K830378 · Abco Dealers, Inc. · Mar 1983