Cleared Traditional

K862002 - MEDISYSTEMS PHERESIS NEEDLE

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

K862002 · Medisystems Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K862002

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 131d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIE Device Classification - Class 2, Special Controls

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 63
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K862002.
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990
TERUMO AV FISTULA NEEDLE SET
K891062 · Terumo Medical Corp. · Jun 1989
JMS APHERESIS NEEDLE
K880726 · Jms Co., Ltd. · Mar 1988
SUPERCATH A.V. FISTULA
K854773 · Togo Medikit Co., Ltd. · Apr 1986
JMD AV FISTULA NEEDLE (MODIFICATION)
K860789 · Jms Co., Ltd. · Mar 1986
JMS AV FISTULA NEEDLE
K860241 · Jms Co., Ltd. · Feb 1986