Cleared Traditional

IVAC NEEDLELESS INJECTION VALVE (K922115) - FDA 510(k) Clearance

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

K922115 · Y · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 1993
Decision
525d
Days
Class 2
Risk

K922115 is an FDA 510(k) clearance for the IVAC NEEDLELESS INJECTION VALVE. 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 October 12, 1993 after a review of 525 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Y devices

Submission Details

510(k) Number K922115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1992
Decision Date October 12, 1993
Days to Decision 525 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
396d slower than avg
Panel avg: 129d · This submission: 525d
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 213
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K922115.
CONTROL-A-FLO(TM) REGULATOR
K940867 · Baxter Healthcare Corp · May 1994
LIFECARE PLUMSET VENTED SECONDARY I.V. SET
K933326 · Abbott Laboratories · Mar 1994
ENERGIZED CONTAINER SYSTEM
K925418 · Abbott Laboratories · Nov 1993
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
K925362 · Baxter Healthcare Corp · Aug 1993
BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET
K925058 · C.R. Bard, Inc. · Aug 1993
BAXTER SOLUTION ADMINISTRATION SETS
K924721 · Baxter Healthcare Corp · Jul 1993