Cleared Traditional

K901803 - SYRINGE NEEDLE INTRODUCER (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901803 · Glaxo, Inc. · General Hospital
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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

Submission Details

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
87d slower than avg
Panel avg: 128d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.