Cleared Traditional

K901803 - SYRINGE NEEDLE INTRODUCER

K901803 is an FDA 510(k) clearance for SYRINGE NEEDLE INTRODUCER, manufactured by Glaxo, Inc.. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K901803 · Glaxo, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
215d
Days
Class 2
Risk

K901803 is an FDA 510(k) clearance for the SYRINGE NEEDLE INTRODUCER. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Glaxo, Inc. (Research Triangle, US). The FDA issued a Cleared decision on November 20, 1990 after a review of 215 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Glaxo, Inc. devices

FDA 510(k) Submission Details - K901803

510(k) Number K901803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1990
Decision Date November 20, 1990
Days to Decision 215 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 129d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZH Device Classification - Class 2, Special Controls

Product Code KZH Introducer, Syringe Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6920
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 General Hospital devices follow this clearance model.

Regulatory Peers - KZH Introducer, Syringe Needle

All 31
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K901803.
PEN-INJECT 2.25
K954729 · Scandinavian Health , Ltd. · Jan 1996
V-CATH PERCUTANEOUS INTRODUCER KIT
K951384 · Hdc Corp. · Jun 1995
V-CATH BREAKAWAY NEEDLE INTRODUCER
K945473 · Hdc Corp. · Jan 1995
DIAMATIC, AUTOMATIC INSULIN INJECTOR
K860284 · Ulster Scientific, Inc. · Apr 1986
MONOJECT INJECTOMATIC
K832683 · Sherwood Medical Co. · Sep 1983