Cleared Traditional

K953225 - IVAC BALL VALCE ADMIN. SETS

K953225 is the FDA 510(k) clearance for IVAC BALL VALCE ADMIN. SETS by Y. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K953225 · Y · General Hospital

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Sep 1995

Decision

79d

Days

Class 2

Risk

K953225 is an FDA 510(k) clearance for the IVAC BALL VALCE ADMIN. SETS. 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 September 27, 1995 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Y devices

Submission Details

510(k) Number	K953225 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 10, 1995
Decision Date	September 27, 1995
Days to Decision	79 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

50d faster than avg

Panel avg: 129d · This submission: 79d

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

Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K953225.

ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET

K953746 · Arrow Intl., Inc. · Jan 1996

LOW PROFILE SAFSITE Y-SITE

K954123 · B.Braun Medical, Inc. · Nov 1995

LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG

K953584 · Abbott Laboratories · Oct 1995

SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER

K952074 · Baxter Healthcare Corp · Jul 1995

BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK

K940697 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994

IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS

K934095 · Y · Aug 1994

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K953225

San Diego, CA · US

JENNIFER S HANKARD

Regulatory profile

78 submissions 78 cleared

100% clearance rate · Active in General Hospital

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