Cleared Traditional

K952074 - SOLUTION SET WITH 1.2 MICRON AIR ELIMIN...

K952074 is the FDA 510(k) clearance for SOLUTION SET WITH 1.2 MICRON AIR ELIMIN... by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K952074 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
86d
Days
Class 2
Risk

K952074 is an FDA 510(k) clearance for the SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on July 27, 1995 after a review of 86 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K952074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1995
Decision Date July 27, 1995
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 465
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K952074.
INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)
K952160 · Medex, Inc. · Sep 1995
VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES
K950153 · Imed Corp. · Aug 1995
FIXED FLOW RATE GRAVITY ADMINISTRATION SETS
K952760 · I-Flow Corp. · Aug 1995
ADMINISTRATION SETS WITH BALL FLOAT
K951922 · Imed Corp. · Jul 1995
VENTED/NON-VENTED GEMINI ADMINISTRATION SET
K944320 · Imed Corp. · Feb 1995
NU-SITE
K943897 · Medex, Inc. · Feb 1995