Cleared Traditional

IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL (K925228) - FDA 510(k) Clearance

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

K925228 · Y · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
287d
Days
Class 2
Risk

K925228 is an FDA 510(k) clearance for the IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL. 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 July 30, 1993 after a review of 287 days - an extended review cycle.

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 K925228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date July 30, 1993
Days to Decision 287 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
158d slower than avg
Panel avg: 129d · This submission: 287d
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 K925228.
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
INTERLINK(TM) INJECTION SITE
K925126 · Baxter Healthcare Corp · Jun 1993
INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET
K921899 · Baxter Healthcare Corp · Apr 1993