Cleared Traditional

K940897 - IVAC NEEDLELESS INFECTION VALVE ADMINIS...

K940897 is the FDA 510(k) clearance for IVAC NEEDLELESS INFECTION VALVE ADMINIS... by Y. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K940897 · Y · General Hospital
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Jun 1994
Decision
118d
Days
Class 2
Risk

K940897 is an FDA 510(k) clearance for the IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on June 22, 1994 after a review of 118 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Y devices

Submission Details

510(k) Number K940897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1994
Decision Date June 22, 1994
Days to Decision 118 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 129d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 278
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K933326 · Abbott Laboratories · Mar 1994