Cleared Traditional

K862002 - MEDISYSTEMS PHERESIS NEEDLE

K862002 is the FDA 510(k) clearance for MEDISYSTEMS PHERESIS NEEDLE by Medisystems Corp.. It is a Class 2 Gastroenterology & Urology device (product code FIE) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K862002 · Medisystems Corp. · Gastroenterology & Urology device
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Jun 1986
Decision
35d
Days
Class 2
Risk

K862002 is an FDA 510(k) clearance for the MEDISYSTEMS PHERESIS NEEDLE. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Medisystems Corp. (Washington, US). The FDA issued a Cleared decision on June 27, 1986 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology 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 Medisystems Corp. devices

Submission Details

510(k) Number K862002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1986
Decision Date June 27, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 130d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIE Needle, Fistula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIE Needle, Fistula

All 22
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K862002.
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
K100520 · Nipro Medical Corporation · Mar 2010
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990
TERUMO AV FISTULA NEEDLE SET
K891062 · Terumo Medical Corp. · Jun 1989
PLUME Y SET
K854951 · Hospal Medical Corp. · Jan 1986
HOSPAL FISTULA NEEDLE
K851453 · Hospal Medical Corp. · Apr 1985
DUAL FLOW NEEDLE
K832136 · Travenol Laboratories, S.A. · Oct 1983