Cleared Traditional

K910641 - INTRODUCER NEEDLES

K910641 is the FDA 510(k) clearance for INTRODUCER NEEDLES by Akcess Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K910641 · Akcess Medical Products, Inc. · Gastroenterology & Urology device
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Apr 1991
Decision
75d
Days
Class 2
Risk

K910641 is an FDA 510(k) clearance for the INTRODUCER NEEDLES. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Akcess Medical Products, Inc. devices

Submission Details

510(k) Number K910641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1991
Decision Date April 29, 1991
Days to Decision 75 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
55d faster than avg
Panel avg: 130d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 115
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K910641.
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
K911315 · Baxter Healthcare Corp · Oct 1991
MINNILERT(R) PRESSURE MONITOR
K913483 · Minntech Corp. · Sep 1991
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
K911106 · Baxter Healthcare Corp · May 1991
Y ADAPTOR
K910321 · Akcess Medical Products, Inc. · Apr 1991
MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.
K895244 · National Medical Care, Medical Products Div., Inc. · Feb 1990
DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095
K896006 · Baxter Healthcare Corp · Dec 1989